Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (tentative version): A retrospective multicenter study

Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (tentative version): A retrospective multicenter study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (tentative version): A retrospective multicenter study Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4416217/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Jul, 2024 Read the published version in Scientific Reports → Version 1 posted 12 You are reading this latest preprint version Abstract Since July 2023, obstetrical disseminated intravascular coagulation (DIC) in Japan has been diagnosed based on the new criteria (tentative version), which assesses the main underlying disease, fibrinogen level, and fibrin/fibrinogen degradation products or D-dimer level. The previous Japanese criteria assessed underlying disease, clinical symptoms, and various laboratory findings. This study aimed to prove the effectiveness, reliability, and validity of the new criteria. We analyzed 212 women with singleton pregnancies who delivered after 22 gestational weeks and experienced blood loss ≥ 1,000 mL during vaginal delivery or ≥ 2,000 mL during cesarean section. Those with missing laboratory findings before receiving blood transfusion at delivery were excluded. In the obstetrical DIC group, the frequency of fibrinogen levels < 150 mg/dL was significantly higher than in the control group (92% vs 4%, p < 0.0001), as was the frequency of scores ≥ 8 according to the previous Japanese criteria (100% vs. 9%, p < 0.0001). The relationship between the overall scores using the new criteria with those using the previous criteria was significantly positive (p < 0.0001). Cronbach alpha was 0.767 and Pearson product-moment correlation coefficient was 0.712 between the new and previous criteria. In conclusion, we proved the effectiveness, reliability, and validity of the Japanese new criteria. Health sciences/Health care/Diagnosis/Physical examination Health sciences/Biomarkers/Diagnostic markers criteria obstetrical disseminated intravascular coagulation tentative version reliability validity Figures Figure 1 Figure 2 Figure 3 Introduction The new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (DIC) (tentative version) was released by the Japan Society of Obstetrics and Gynecology (JSOG) and the Japan Society of Obstetrical, Gynecological and Neonatal Hematology (JSOGNH) in June 2022 1 . This tentative version was a revision of the 1985 Japanese criteria for obstetrical DIC score 2, 3 , which assessed three factors: underlying disease, clinical symptoms, and laboratory findings (see Supplementary Table S1 online). The JSOGNH conducted a national surveillance questionnaire and retrospective cohort study to investigate the capability of different types of medical institutions in Japan to manage obstetrical DIC 4 . The DIC score is used as a predictor of the necessity for an immediate transfer of women with postpartum hemorrhage (PPH) from primary maternal facilities to perinatal medical centers. The study revealed that the number of medical institutions that always used the obstetrical DIC score criteria to diagnose obstetrical DIC was significantly lower for primary maternal facilities than for perinatal medical centers. Thus, the JSOGNH decided to revise the obstetrical DIC score to make it easier to use at any type of healthcare facility regardless of its capacity. The JSOGNH also conducted a multicenter retrospective cohort study including seven perinatal medical centers to investigate the main underlying disease in obstetrical DIC and determine the role of hypofibrinogenemia levels as a predictor of obstetrical DIC 5 . JSOG and JSOGNH used these findings to revise the DIC score parameters and develop the Japanese new criteria (tentative version), which assesses three factors: main underlying disease, plasma fibrinogen level, and level of plasma fibrin/fibrinogen degradation products (FDP) or D-dimer. The main underlying diseases include placental abruption, amniotic fluid embolism, and PPH with coagulopathy (Table 1 ). A total score ≥ 8 points indicates a diagnosis of obstetrical DIC 1 . Table 1 Diagnostic criteria for obstetrical DIC (tentative version) [ 1 ] I. Underlying disease/pathology (select only one) Points II. Coagulability finding Points III. Fibrinolysis finding (select either a or b) Points a. Placental abruption b. Amniotic fluid embolism c. Postpartum hemorrhage with coagulopathy 4 4 4 Fibrinogen (mg/dL) ≤ 300 ≥ 200 to < 300 ≥ 150 to < 200 ≥ 100 to < 150 < 100 0 1 2 3 4 a. FDP (µg/mL) < 30 ≥ 30 to < 60 ≥ 60 b. D-dimer (µg/mL) < 15 ≥ 15 to < 25 ≥ 25 0 1 2 0 1 2 Obstetrical DIC is diagnosed if the total of the three factors is ≥ 8 points DIC; disseminated intravascular coagulation, FDP; fibrin-fibrinogen degradation product The new criteria (tentative version) have been used to diagnose obstetrical DIC since July 2023 in Japan. However, their validity and reliability were never evaluated. The aim of this study was to prove the effectiveness, reliability, and validity of the criteria (tentative version) so that they could be accepted as the final version. Results Participants Figure 1 shows the flow chart of study participants. Of 7,744 women with singleton pregnancies women who delivered after 22 gestational weeks, 677 experienced massive PPH, with 532 losing ≥ 1,000 mL of blood during vaginal delivery and 145 losing ≥ 2,000 mL of blood loss during cesarean section. Of them, 465 were missing laboratory test results before receiving blood transfusion at delivery and were excluded. The final study cohort comprised 212 women, including 121 with blood loss during vaginal delivery ≥ 1,000 mL and 91 with blood loss during cesarean section ≥ 2,000 mL. These 212 women were divided into an obstetrical DIC group (n = 12) and a control group (n = 200) according to the new Japanese criteria (tentative version). Characteristics, treatments, and maternal/neonatal outcomes Table 2 presents the characteristics of the obstetrical DIC and control groups. The median maternal age, frequency of primiparity, median gestational weeks at delivery, and frequency of women who had undergone cesarean section were similar for both groups. The median blood loss at cesarean section was similar for both groups, but the median blood loss at vaginal delivery in the obstetrical DIC group was significantly higher (p < 0.0001) than in the control group. Table 2 Characteristics of participants Overall (n = 212) Obstetrical DIC (n = 12) Control (n = 200) P value Age (years) 36 [19–46] 35 [27–45] 36 [19–46] 0.5816 Primiparous (%) 123 (58.0%) 4 (33.3%) 119 (59.5%) 0.1289 Gestational weeks at delivery (weeks) 39.4 [26.9–41.6] 39.9 [26.9–41.1] 39.4 [28.7–41.6] 0.8761 Cesarean section (%) 49 (23.1%) 4 (33.3%) 45 (22.5%) 0.4788 Blood loss at delivery (mL) 1824 [1001–7748] 4603 [2019–7748] 1742 [1001–6742] < 0.0001 ≥3000 mL (%) 35 (16.5%) 9 (75.0%) 26 (13.0%) < 0.0001 ≥5000 mL (%) 9 (4.2%) 6 (50.0%) 3 (1.5%) < 0.0001 Cesarean section 2452 [2000–6742] 4223 [2019–5780] 2384 [2000–6742] 0.2144 Vaginal delivery 1537 [1001–7748] 4810 [2702–7748] 1500 [1001–6716] < 0.0001 Maternal outcomes Intrauterine balloon packing (%) 56 (27.6%) 7 (58.3%) 49 (25.7%) 0.0211 Interventional radiology (%) 8 (4.0%) 2 (16.7%) 6 (3.2%) 0.0743 Hysterectomy (%) 4 (1.9%) 2 (16.7%) 2 (1.0%) 0.0182 Maternal death (%) 1 (0.47%) 1 (8.3%) 0 (0.0%) 0.0566 Neonatal outcomes Birthweight (g) 3195 [1004–4182] 2959 [1004–3912] 3195 [1238–4182] 0.1444 Stillbirth (%) 3 (1.4%) 2 (16.7%) 1 (0.5%) 0.0086 Early neonatal death (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) - DIC: disseminated intravascular coagulation Regarding PPH treatments, the frequencies of intrauterine balloon packing and/or hysterectomy in the obstetrical DIC group were significantly higher (p = 0.0211 and p = 0.0182, respectively) than in the control group. A comparison of the maternal/neonatal outcomes between the two groups revealed that the frequency of maternal death in the obstetrical DIC group tended to be higher than in the control group. The frequency of stillbirth in the obstetrical DIC group was significantly higher (p = 0.0086) than in the control group. Underlying disease/pathology and laboratory findings Table 3 shows the underlying disease/pathology and the laboratory findings of the study cohort. In the obstetrical DIC group, the rate of underlying disease/pathology and levels of FDP and D-Dimer were significantly higher (p < 0.0001) and the level of fibrinogen was significantly lower (p < 0.0001) compared with those in the control group. Notably, the frequency of women with fibrinogen levels < 150 mg/dL in the obstetrical DIC group was significantly higher (p < 0.0001) than in the control group. Furthermore, the median platelet count and antithrombin activity were significantly lower (p < 0.0001 and p = 0.0103, respectively) in the obstetrical DIC group than in the control group. Table 3 Underlying disease/pathology and laboratory findings of participants Overall (n = 212) Obstetrical DIC (n = 12) Control (n = 200) P value Obstetrical DIC scores (points) 1 [0–10] 10 [ 8 – 10 ] 0 [0–7] < 0.0001 I. Underlying disease/pathology (points) 0 [0–4] 4 [ 4 – 4 ] 0 [0–4] < 0.0001 One or more 25 (11.8%) 12 (100%) 13 (6.5%) < 0.0001 Placental abruption 6 (2.8%) 2 (16.7%) 4 (2.0%) 0.0389 Amniotic fluid embolism 2 (0.94%) 2 (16.7%) 0 (0.0%) 0.0030 Postpartum hemorrhage with coagulopathy 19 (9.0%) 10 (83.3%) 9 (4.5%) < 0.0001 II. Coagulability finding (points) 0 [0–4] 4 [ 2 – 4 ] 0 [0–4] < 0.0001 Fibrinogen (mg/dL) 321 [24–634] 78 [24–194] 332 [53–634] < 0.0001 < 150 mg/dL 19 (9.0%) 11 (91.7%) 8 (4.0%) < 0.0001 III. Fibrinolysis finding (points) 0 [0–2] 2 [0–2] 0 [0–2] < 0.0001 FDP (µg/mL) 22.2 [2.7–960] 500 [19.4–960] 20.5 [2.7–850] < 0.0001 D-dimer (µg/mL) 7.4 [1.2–400] 203 [10.1–400] 6.8 [1.2–300] < 0.0001 Other laboratory findings Platelets counts (×10 9 /L) 179 [19–385] 113 [19–150] 185 [43–385] < 0.0001 Antithrombin activity (%) 68.0 [22.9–104.0] 45.2 [25.0–82.0] 68.8 [22.9–104.0] 0.0103 Obstetrical DIC score [previous] (points) 2 [0–33] 12 [4–33] 2 [0–16] < 0.0001 ≥8 points 30 (14.2%) 12 (100%) 18 (9.0%) < 0.0001 DIC; disseminated intravascular coagulation, FDP; fibrin-fibrinogen degradation product All women in the obstetrical DIC group had an obstetrical DIC score (previous criteria) ≥ 8 points. The overall obstetrical DIC score (previous criteria) and the frequency of overall obstetrical DIC scores (previous criteria) ≥ 8 points in the obstetrical DIC group were significantly higher (p < 0.0001, respectively) than in the control group (Table 3 ). The obstetrical DIC score was significantly correlated with blood loss at delivery and with the levels of fibrinogen, FDP, and D-dimer (all p < 0.0001; Fig. 2 ). Blood transfusion and/or blood product therapies The frequencies of transfusions of fresh frozen plasma and red blood cell, platelet, and fibrinogen concentrate in the obstetrical DIC group were significantly higher (p < 0.0001) than those in the control group (Table 4 ). Table 4 Blood transfusion and/or blood product therapies Overall (n = 212) Obstetrical DIC (n = 12) Control (n = 200) P value FFPs (and cryoprecipitate *) 56 (26.4%) 12 (100%) 44 (22.0%) < 0.0001 Dosage (units) 0 [0–50] 9 [4–50] 0 [0–32] < 0.0001 Fibrinogen concentrates 20 (9.4%) 10 (83.3%) 10 (5.0%) < 0.0001 Dosage (g) 0 [0–12] 3 [0–12] 0 [0–6] < 0.0001 RBCs 86 (40.6%) 12 (100%) 74 (37.0%) < 0.0001 Dosage (units) 0 [0–54] 4 [14–54] 0 [0–42] < 0.0001 PCs 11 (5.2%) 5 (41.7%) 6 (3.0%) < 0.0001 Dosage (units) 0 [0–40] 0 [0–40] 0 [0–40] < 0.0001 Autologous blood 16 (7.5%) 0 (0.0%) 16 (8.0%) 0.6058 Dosage (units) 0 [0–8] 0 [0–0] 0 [0–8] 0.3098 Antithrombin products 11 (5.2%) 1 (8.3%) 10 (5.0%) 0.4816 Dosage (units) 0 [0–3000] 0 [0–3000] 0 [0–3000] 0.5791 DIC; disseminated intravascular coagulation, FFP; fresh frozen plasma, RBC; red cell concentrates, PC; platelet concentrates. * cryoprecipitates; both group had one woman, respectively. Comparison of reliability and validity of new criteria (tentative version) with previous criteria There was a significantly positive relationship between the overall obstetrical DIC scores using the new criteria (tentative version) and the overall obstetrical DIC scores using the previous criteria (Fig. 3 a). Cronbach alpha was 0.767 and Pearson product-moment correlation coefficient was 0.712 between the new criteria and previous criteria. These findings verified the reliability and validity of the new criteria (tentative version) in comparison with the previous criteria. The frequency of women with fibrinogen levels < 150 mg/dL diagnosed with obstetrical DIC according to the new criteria was significantly higher than in women diagnosed with obstetrical DIC according to the previous criteria (p < 0.0006; Fig. 3 b). Discussion Our study results revealed three key points. First, the new Japanese diagnostic criteria for obstetrical DIC (tentative version) was effective for the diagnosis of obstetrical DIC in women with PPH. Second, almost all women with obstetrical DIC had hypofibrinogenemia. Conversely, almost all women without obstetrical DIC did not have hypofibrinogenemia. Third, a comparison of the new criteria with the obstetrical DIC score (previous criteria) proved the reliability and validity of the new criteria. The scoring system of the previous criteria was complicated. There were three significant differences between the previous criteria and the new criteria 1 . First, both criteria had placental abruption and amniotic fluid embolism as underlying diseases. The previous criteria also had DIC type-PPH, eclampsia, and others as underlying diseases, but the new criteria only had PPH with coagulopathy. Second, compared with the previous criteria, the new criteria excluded clinical symptoms. Third, the new criteria did not include all the laboratory findings from the previous criteria (notably platelet count and prothrombin time). Regarding underlying diseases, the previous criteria did not define DIC type-PPH. In the new criteria, PPH with coagulopathy was defined as massive PPH without blood clots 1, 3 . Thus, it should be checked that the hemorrhage collected in the basin does not form a blood clot. The previous criteria had five categories of clinical symptoms (acute renal failure, acute respiratory failure excluding amniotic fluid embolism, organ failure, hemorrhage diathesis, and shock symptoms), which included a total of 13 factors 3 , and the clinical symptoms were sufficiently specific to effectively diagnose critical obstetric hemorrhage. In contrast, the new criteria are specific to the diagnosis of obstetrical DIC. The platelet count was excluded as a laboratory finding in the new criteria because platelets are involved in primary hemostasis, and fibrinogen was included because it is involved in secondary hemostasis 6 . In the obstetrical DIC, there is a malfunction of not only the primary hemostasis system but also the secondary hemostasis system. If the secondary hemostasis system is compromised, this leads to certain death; thus hypofibrinogenemia and hypercoagulation (high levels of FDP and/or D-dimer) are critical laboratory findings. Therefore, the new criteria consider fibrinogen and FDP/D-dimer levels more important than platelet counts. Overt DIC is diagnosed worldwide according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) published in 2001 7 . Erez et. al. published the pregnancy-specific modified ISTH DIC score in 2014 8 , which included underlying disease and clinical symptoms as factors to diagnose obstetrical DIC (see Supplementary Table S1 online). The inclusion of underlying diseases as one of the factors in both the previous and new Japanese criteria is a clear departure from the worldwide criteria 1–3 . Regarding the laboratory findings, the overt DIC diagnostic criteria included platelet count, FDP/D-dimer/soluble fibrin, fibrinogen, and prothrombin time, while the pregnancy-specific modified ISTH DIC score included prothrombin time difference, platelet count, and fibrinogen level. The new Japanese criteria do not include platelet count as one of the factors, which is a clear deviation from the worldwide criteria 1 . Thus, the new Japanese criteria are globally unique. A retrospective single-center case-control study demonstrated that the new Japanese criteria detected more severe cases of obstetrical DIC that needed treatment with a higher number of transfusions of fresh frozen plasma and/or cryoprecipitate, red blood cell concentrate, and platelet concentrate compared with the pregnancy-specific modified ISTH DIC score 9 . In our study, the new Japanese criteria detected more severe cases of obstetrical DIC compared with the previous obstetrical DIC score. Thus, the frequency of pregnant women diagnosed with obstetrical DIC may decrease in Japan with the use of the new criteria. This study had two limitations: the sample size was small and the study design was retrospective, not prospective. Thus, a multicenter prospective study is necessary to confirm our findings. Conclusion We proved the effectiveness, reliability, and validity of the new Japanese diagnostic criteria for obstetrical DIC (tentative version). Thus, they can be accepted as the final version. Methods Study design and Setting This retrospective multicenter cohort study was conducted at eight institutions (Aiiku Hospital, Juntendo University Juntendo Hospital, Juntendo University Urayasu Hospital, Kansai Medical University Hospital, Hamamatsu Medical Center, Mie University School of Medicine, Okayama University Hospital, and Saitama Medical University Saitama Medical Center) supported by JSOGNH. Data collection Data were collected from the medical records of pregnant women with massive PPH (blood loss ≥ 1,000 mL during vaginal delivery or ≥ 2,000 mL during cesarean section), including maternal and neonatal characteristics, underlying diseases, and laboratory test results (fibrinogen and FDP or D-dimer) before and after treatment for obstetrical DIC (transfusion of blood or blood products). Inclusion and exclusion criteria Between July 2022 and June 2023, 7,744 women with a singleton pregnancy delivered after 22 gestational weeks at the eight predetermined institutions. Those with massive PPH were included in the study cohort. Women who had received a transfusion of blood or blood products at a primary facility prior to being transferred to one of the eight institutions were excluded, as were those with one or more missing laboratory results before receiving blood transfusion at delivery. Diagnosis and treatment of obstetrical DIC Obstetrical DIC was diagnosed at all institutions according to the new criteria for obstetrical DIC (tentative version) (Table 1 ). All women with obstetrical DIC were treated as per JSOG 10 and JSOGNH recommendations 11 . According to the previously used Japanese obstetrical DIC score, a total score ≥ 8 indicates DIC suspicion and a total score ≥ 13 (including ≥ 2 points for laboratory findings) confirms DIC (see Supplementary Table S1 online) 2, 3 . In the present study, we considered an obstetrical DIC score ≥ 8 as confirmation of DIC. Sample size calculation According to the hypothesis of a study population with the primary outcome as the presence of hypofibrinogenemia (fibrinogen < 150 mg/dL), we calculated that the study cohort required four women with obstetrical DIC and 80 women without obstetrical DIC. Thus, the ideal minimum sample size was 49 if the rates of hypofibrinogenemia were 80% among women with obstetrical DIC and 20% among women without obstetrical DIC and the ratio of women with obstetrical DIC to those without obstetrical DIC was 1:20 (rate of obstetrical DIC in women with massive PPH was 5%) with an error level of 0.05 and power of 0.8. Statistical analysis Data were presented as medians (minimum–maximum) or numbers (%). Statistical analyses were performed using JMP Pro v17.0 (SAS Institute Inc., Cary, NC, USA). We used Tukey–Kramer honestly significant difference test, Wilcoxon signed rank test, or Mann–Whitney U test to compare medians (minimum–maximum) and Fisher exact test to compare categorical variables. P-values < 0.05 were considered to indicate statistical significance for all analyses. Ethics This study was conducted in accordance with the principles of the Declaration of Helsinki and approved en bloc for all institutions by the Kansai Medical University Hospital Institutional Review Board (approval no. 2022042; accepted April 24, 2023). All study participants provided informed consent. Declarations Acknowledgments The authors thank Enago (www.enago.jp) for the English language review. The authors thank the Working Group for Revision of Obstetric DIC Score in the Japan Society of Obstetrical, Gynecological and Neonatal Hematology. Author contributions Conceptualization: Mamoru Morikawa, Atsuo Itakura Data curation: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda. Formal analysis: Mamoru Morikawa, Atsuo Itakura Funding acquisition: Mamoru Morikawa Investigation: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda. Methodology: Mamoru Morikawa, Hisashi Masuyama, Atsuo Itakura Project administration: Mamoru Morikawa, Hisashi Masuyama, Atsuo Itakura Resources: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Masafumi Nii, Mariko Serizawa, Jun Takeda. Software: Mamoru Morikawa Supervision: Hisashi Masuyama, Atsuo Itakura Validation: Mamoru Morikawa, Shigetaka Matsunaga, Shintaro Makino, Atsuo Itakura Visualization: Mamoru Morikawa, Atsuo Itakura Writing–original draft: Mamoru Morikawa Writing–review & editing: Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda, Hisashi Masuyama, Atsuo Itakura Competing Interests Statement The authors declare that they have no conflict of interest. Data availability The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request. Ethics declaration This study was approved en bloc for all institutions by the Kansai Medical University Hospital Institutional Review Board (approval no. 2022042; accepted April 24, 2023). All study participants provided informed consent. Additional Information Financial disclosure statement The first author (Mamoru Morikawa) received funding for this work from Japan Blood Products Organization (Tokyo, Japan. URL: https://www.jbpo.or.jp/english/). References Itakura, A., et al. Disseminated intravascular coagulation (DIC) in obstetrics field: diagnostic criteria for obstetrical DIC (Tentative version). Jpn. J. Obstet. Gynecol. Neonatal. Hematol.32, 43–49 (2023). Maki, M., Terao, T,, Ikenoue, K. Obstetrical DIC score. Obstet. Gynecol. Therapy. 50,119–124 (1985). Kobayashi, T. Obstetrical disseminated intravascular coagulation score. J. Obstet. Gynaecol. Res. 40, 1500–1506 (2014). Morikawa, M., Nii, M., Nakabayashi, Y., Itakura, A., Kobayashi, T., Adachi, T. Capacity of Japanese institutions to manage obstetrical disseminated intravascular coagulation in 2018: A national surveillance questionnaire and retrospective cohort study. J. Obstet. Gynaecol. Res. 47 3159–3170 (2021). Morikawa, M., et al. Effect of hypofibrinogenemia on obstetrical disseminated intravascular coagulation in Japan in 2018: a multicenter retrospective cohort study. Int. J. Hematol. 114, 18–34 (2021). Winter, W.E., Flax, S.D., Harris, N.S. Coagulation testing in the core laboratory. Lab Med. 48, 295–313 (2017). Taylor, F.B. Jr., Toh, C.H., Hoots, W.K., Wada, H., Levi, M. Scientific subcommittee on disseminated intravascular coagulation (DIC) of the International Society on Thrombosis and Hemostasis (ISTH). Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation. Thromb Haemost. 86, 1327–1330 (2001). Erez, O., et al. DIC score in pregnant women–a population based modification of the International Society on thrombosis and hemostasis score. PLoS One. 9, e93240 (2014). Morikawa, M., Kamiya, A., Yoshida, A., Nishibata, S., Okada, H. Differences between Japanese new criteria and pregnancy-specific modified ISTH DIC scores for obstetrical DIC diagnosis. Int. J. Hematol. 119, 265–274. Itakura, A., et al. Guidelines for obstetrical practice in Japan: Japan Society of Obstetrics and Gynecology and Japan Association of Obstetricians and Gynecologists 2020 edition. J. Obstet. Gynaecol. Res. 49,5–53 (2023). Kobayashi, T., Terao, T., Maki, M., Ikenoue, T. Diagnosis and management of acute obstetrical DIC. Semin. Thromb. Hemost. 27, 161–167 (2001). Additional Declarations No competing interests reported. Supplementary Files ObstetricalDICSupplementalTable12024SciRep.docx Cite Share Download PDF Status: Published Journal Publication published 30 Jul, 2024 Read the published version in Scientific Reports → Version 1 posted Editorial decision: Revision requested 05 Jun, 2024 Reviews received at journal 03 Jun, 2024 Reviews received at journal 29 May, 2024 Reviewers agreed at journal 20 May, 2024 Reviews received at journal 19 May, 2024 Reviewers agreed at journal 19 May, 2024 Reviewers agreed at journal 19 May, 2024 Reviewers invited by journal 18 May, 2024 Editor assigned by journal 18 May, 2024 Editor invited by journal 15 May, 2024 Submission checks completed at journal 15 May, 2024 First submitted to journal 13 May, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Morikawa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABB0lEQVRIiWNgGAWjYBADOQNmBgbGBhCTByoE4eEGxlAtBsRrSdzAgK4FF9Cddvjpho97DqdvZ+d9+HFGzR95Bp7TaRIMNXYMzLOxW2N2O83s5oxnh3N3NrMbS244ZmDYwNu7TYLhWDID45wDOLQkmN3mOXA4d8NhNgbJB2wGjA38vEAtbAcYGGck4NCS/g2kJd3gMBvzzwf/DOwhWv7h05IDtiUBqIVNcmObQSLYYYxteLWU3ZxxIN0Q6DA2y5l9xsltPGc3WyT2JfPg9kv6thsfDljLG5w/xnyz55ucbT9P7sYbH77ZyRniCDFMwAYigE7iMZxBpA4EkJcgWcsoGAWjYBQMTwAAAfJhkRftpxEAAAAASUVORK5CYII=","orcid":"","institution":"Kansai Medical University","correspondingAuthor":true,"prefix":"","firstName":"Mamoru","middleName":"","lastName":"Morikawa","suffix":""},{"id":304617354,"identity":"59bb14a3-7b77-4734-b426-789412f35001","order_by":1,"name":"Yoshiharu Takeda","email":"","orcid":"","institution":"Aiiku Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yoshiharu","middleName":"","lastName":"Takeda","suffix":""},{"id":304617358,"identity":"173d85b9-017c-439e-88f4-c19fb483ef93","order_by":2,"name":"Shigetaka Matsunaga","email":"","orcid":"","institution":"Saitama Medical University, Saitama Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Shigetaka","middleName":"","lastName":"Matsunaga","suffix":""},{"id":304617359,"identity":"4e7c6c23-f753-41d0-876b-1c4354e9027a","order_by":3,"name":"Shintaro Makino","email":"","orcid":"","institution":"Juntendo University, Urayasu Hospital","correspondingAuthor":false,"prefix":"","firstName":"Shintaro","middleName":"","lastName":"Makino","suffix":""},{"id":304617360,"identity":"d7ba3119-3fd7-4fcf-a657-92f42ebf416f","order_by":4,"name":"Eriko Eto","email":"","orcid":"","institution":"Okayama University","correspondingAuthor":false,"prefix":"","firstName":"Eriko","middleName":"","lastName":"Eto","suffix":""},{"id":304617362,"identity":"84f46991-5c10-40ba-9d48-cacc0ef39bb3","order_by":5,"name":"Mariko Serizawa","email":"","orcid":"","institution":"Hamamatsu Medical Center","correspondingAuthor":false,"prefix":"","firstName":"Mariko","middleName":"","lastName":"Serizawa","suffix":""},{"id":304617364,"identity":"03a04a4b-1eb3-4331-976f-6a19526fb35e","order_by":6,"name":"Masafumi Nii","email":"","orcid":"","institution":"Mie University School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Masafumi","middleName":"","lastName":"Nii","suffix":""},{"id":304617366,"identity":"bd2412f9-d6df-4db0-a4f4-66dfb23d67ef","order_by":7,"name":"Jun Takeda","email":"","orcid":"","institution":"Juntendo University Graduate School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Jun","middleName":"","lastName":"Takeda","suffix":""},{"id":304617368,"identity":"757dea0f-3acc-42f8-b3bc-44dbd591fc1a","order_by":8,"name":"Hisashi Masuyama","email":"","orcid":"","institution":"Okayama University","correspondingAuthor":false,"prefix":"","firstName":"Hisashi","middleName":"","lastName":"Masuyama","suffix":""},{"id":304617370,"identity":"636f9cf5-ac9b-4140-b605-4d5468264aca","order_by":9,"name":"Atsuo Itakura","email":"","orcid":"","institution":"Juntendo University Graduate School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Atsuo","middleName":"","lastName":"Itakura","suffix":""}],"badges":[],"createdAt":"2024-05-14 03:37:00","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4416217/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4416217/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41598-024-68298-7","type":"published","date":"2024-07-30T15:58:14+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":57073359,"identity":"3990be7d-6d99-47cd-8728-e734ce882657","added_by":"auto","created_at":"2024-05-24 08:49:21","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":376253,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow chart of study participants.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDIC, disseminated intravascular coagulation.\u003c/p\u003e","description":"","filename":"ObstetricalDICFig12024SciRep.png","url":"https://assets-eu.researchsquare.com/files/rs-4416217/v1/f6d28bf82d29d06f8e223180.png"},{"id":57073360,"identity":"dc52122a-6cce-4b67-af33-1dd8e090bb1a","added_by":"auto","created_at":"2024-05-24 08:49:21","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":503958,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eRelationship between obstetrical DIC score and blood loss at delivery/laboratory findings.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe women shown in the gray areas were diagnosed with obstetrical DIC according to the new Japanese diagnostic criteria (tentative version). Relationship between obstetrical DIC score and blood loss at delivery (a), obstetrical DIC score and fibrinogen level (b), obstetrical DIC score and FDP level (c), and obstetrical DIC score and D-dimer level (d). DIC, disseminated intravascular coagulation; FDP, fibrinogen/fibrin degradation products.\u003c/p\u003e","description":"","filename":"ObstetricalDICFig22024SciRep.png","url":"https://assets-eu.researchsquare.com/files/rs-4416217/v1/0b3cafa36ae72c2d3f0c9421.png"},{"id":57074269,"identity":"62ca7cf2-399e-4dbf-8df1-414e5deb9437","added_by":"auto","created_at":"2024-05-24 08:57:21","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":385905,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eRelationship between new and previous diagnostic criteria for obstetrical DIC.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ea. Relationship between the obstetrical DIC score using the previous criteria and the obstetrical DIC score using the new criteria. The women shown in the gray areas were diagnosed with obstetrical DIC according to the new Japanese diagnostic criteria for obstetrical DIC (tentative version). b. Frequency of women with fibrinogen \u0026lt;150 mg/dL in women with/without an obstetrical DIC score ≥8 points. DIC, disseminated intravascular coagulation\u003c/p\u003e","description":"","filename":"ObstetricalDICFig32024SciRep.png","url":"https://assets-eu.researchsquare.com/files/rs-4416217/v1/b96e53ac8c17e31afa0cbca3.png"},{"id":61793791,"identity":"ceb6161d-f5e2-4617-8211-42d604289d1c","added_by":"auto","created_at":"2024-08-05 16:15:33","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1900517,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4416217/v1/5c752dcf-3e91-447b-824d-6802c4766fca.pdf"},{"id":57073358,"identity":"92d3436e-d487-4631-96b3-65d8f788db1a","added_by":"auto","created_at":"2024-05-24 08:49:21","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":21141,"visible":true,"origin":"","legend":"","description":"","filename":"ObstetricalDICSupplementalTable12024SciRep.docx","url":"https://assets-eu.researchsquare.com/files/rs-4416217/v1/c0513f86aa487c3bb6c52980.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (tentative version): A retrospective multicenter study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (DIC) (tentative version) was released by the Japan Society of Obstetrics and Gynecology (JSOG) and the Japan Society of Obstetrical, Gynecological and Neonatal Hematology (JSOGNH) in June 2022 \u003csup\u003e1\u003c/sup\u003e. This tentative version was a revision of the 1985 Japanese criteria for obstetrical DIC score \u003csup\u003e2, 3\u003c/sup\u003e, which assessed three factors: underlying disease, clinical symptoms, and laboratory findings (see Supplementary Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e online).\u003c/p\u003e \u003cp\u003eThe JSOGNH conducted a national surveillance questionnaire and retrospective cohort study to investigate the capability of different types of medical institutions in Japan to manage obstetrical DIC \u003csup\u003e4\u003c/sup\u003e. The DIC score is used as a predictor of the necessity for an immediate transfer of women with postpartum hemorrhage (PPH) from primary maternal facilities to perinatal medical centers. The study revealed that the number of medical institutions that always used the obstetrical DIC score criteria to diagnose obstetrical DIC was significantly lower for primary maternal facilities than for perinatal medical centers. Thus, the JSOGNH decided to revise the obstetrical DIC score to make it easier to use at any type of healthcare facility regardless of its capacity. The JSOGNH also conducted a multicenter retrospective cohort study including seven perinatal medical centers to investigate the main underlying disease in obstetrical DIC and determine the role of hypofibrinogenemia levels as a predictor of obstetrical DIC \u003csup\u003e5\u003c/sup\u003e. JSOG and JSOGNH used these findings to revise the DIC score parameters and develop the Japanese new criteria (tentative version), which assesses three factors: main underlying disease, plasma fibrinogen level, and level of plasma fibrin/fibrinogen degradation products (FDP) or D-dimer. The main underlying diseases include placental abruption, amniotic fluid embolism, and PPH with coagulopathy (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). A total score\u0026thinsp;\u0026ge;\u0026thinsp;8 points indicates a diagnosis of obstetrical DIC \u003csup\u003e1\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDiagnostic criteria for obstetrical DIC (tentative version) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI. Underlying disease/pathology\u003c/p\u003e \u003cp\u003e(select only one)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePoints\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eII. Coagulability finding\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePoints\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIII. Fibrinolysis finding\u003c/p\u003e \u003cp\u003e(select either\u003c/p\u003e \u003cp\u003ea or b)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePoints\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ea. Placental abruption\u003c/p\u003e \u003cp\u003eb. Amniotic fluid embolism\u003c/p\u003e \u003cp\u003ec. Postpartum hemorrhage with coagulopathy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFibrinogen (mg/dL)\u003c/p\u003e \u003cp\u003e\u0026le;\u0026thinsp;300\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;200 to \u0026lt;\u0026thinsp;300\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;150 to \u0026lt;\u0026thinsp;200\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;100 to \u0026lt;\u0026thinsp;150\u003c/p\u003e \u003cp\u003e\u0026lt;\u0026thinsp;100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e3\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003ea. FDP (\u0026micro;g/mL)\u003c/p\u003e \u003cp\u003e\u0026lt;\u0026thinsp;30\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;30 to \u0026lt;\u0026thinsp;60\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;60\u003c/p\u003e \u003cp\u003eb. D-dimer (\u0026micro;g/mL)\u003c/p\u003e \u003cp\u003e\u0026lt;\u0026thinsp;15\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;15 to \u0026lt;\u0026thinsp;25\u003c/p\u003e \u003cp\u003e\u0026ge;\u0026thinsp;25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e \u003cp\u003eObstetrical DIC is diagnosed if the total of the three factors is \u0026ge;\u0026thinsp;8 points\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eDIC; disseminated intravascular coagulation, FDP; fibrin-fibrinogen degradation product\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThe new criteria (tentative version) have been used to diagnose obstetrical DIC since July 2023 in Japan. However, their validity and reliability were never evaluated. The aim of this study was to prove the effectiveness, reliability, and validity of the criteria (tentative version) so that they could be accepted as the final version.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eFigure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the flow chart of study participants. Of 7,744 women with singleton pregnancies women who delivered after 22 gestational weeks, 677 experienced massive PPH, with 532 losing\u0026thinsp;\u0026ge;\u0026thinsp;1,000 mL of blood during vaginal delivery and 145 losing\u0026thinsp;\u0026ge;\u0026thinsp;2,000 mL of blood loss during cesarean section. Of them, 465 were missing laboratory test results before receiving blood transfusion at delivery and were excluded. The final study cohort comprised 212 women, including 121 with blood loss during vaginal delivery\u0026thinsp;\u0026ge;\u0026thinsp;1,000 mL and 91 with blood loss during cesarean section\u0026thinsp;\u0026ge;\u0026thinsp;2,000 mL. These 212 women were divided into an obstetrical DIC group (n\u0026thinsp;=\u0026thinsp;12) and a control group (n\u0026thinsp;=\u0026thinsp;200) according to the new Japanese criteria (tentative version).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eCharacteristics, treatments, and maternal/neonatal outcomes\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e presents the characteristics of the obstetrical DIC and control groups. The median maternal age, frequency of primiparity, median gestational weeks at delivery, and frequency of women who had undergone cesarean section were similar for both groups. The median blood loss at cesarean section was similar for both groups, but the median blood loss at vaginal delivery in the obstetrical DIC group was significantly higher (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) than in the control group.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eCharacteristics of participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;212)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObstetrical\u003c/p\u003e \u003cp\u003eDIC (n\u0026thinsp;=\u0026thinsp;12)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;200)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36 [19\u0026ndash;46]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35 [27\u0026ndash;45]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e36 [19\u0026ndash;46]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5816\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimiparous (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e123 (58.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e119 (59.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.1289\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGestational weeks\u003c/p\u003e \u003cp\u003eat delivery (weeks)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e39.4\u003c/p\u003e \u003cp\u003e[26.9\u0026ndash;41.6]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39.9\u003c/p\u003e \u003cp\u003e[26.9\u0026ndash;41.1]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e39.4\u003c/p\u003e \u003cp\u003e[28.7\u0026ndash;41.6]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.8761\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCesarean section (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e49 (23.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (33.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e45 (22.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.4788\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlood loss at delivery\u003c/p\u003e \u003cp\u003e(mL)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1824\u003c/p\u003e \u003cp\u003e[1001\u0026ndash;7748]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4603\u003c/p\u003e \u003cp\u003e[2019\u0026ndash;7748]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1742\u003c/p\u003e \u003cp\u003e[1001\u0026ndash;6742]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;3000 mL (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (16.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (75.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e26 (13.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;5000 mL (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (4.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (50.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (1.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCesarean section\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2452\u003c/p\u003e \u003cp\u003e[2000\u0026ndash;6742]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4223\u003c/p\u003e \u003cp\u003e[2019\u0026ndash;5780]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2384\u003c/p\u003e \u003cp\u003e[2000\u0026ndash;6742]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.2144\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVaginal delivery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1537\u003c/p\u003e \u003cp\u003e[1001\u0026ndash;7748]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4810\u003c/p\u003e \u003cp\u003e[2702\u0026ndash;7748]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1500\u003c/p\u003e \u003cp\u003e[1001\u0026ndash;6716]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMaternal outcomes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntrauterine\u0026nbsp;balloon\u003c/p\u003e \u003cp\u003epacking (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56 (27.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (58.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e49 (25.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0211\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInterventional radiology (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (4.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (3.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0743\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHysterectomy (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (1.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (1.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0182\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMaternal death (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (0.47%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0566\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNeonatal outcomes\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBirthweight (g)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3195\u003c/p\u003e \u003cp\u003e[1004\u0026ndash;4182]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2959\u003c/p\u003e \u003cp\u003e[1004\u0026ndash;3912]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3195\u003c/p\u003e \u003cp\u003e[1238\u0026ndash;4182]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.1444\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStillbirth (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (1.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (0.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0086\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEarly neonatal death\u003c/p\u003e \u003cp\u003e(%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eDIC: disseminated intravascular coagulation\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eRegarding PPH treatments, the frequencies of intrauterine balloon packing and/or hysterectomy in the obstetrical DIC group were significantly higher (p\u0026thinsp;=\u0026thinsp;0.0211 and p\u0026thinsp;=\u0026thinsp;0.0182, respectively) than in the control group. A comparison of the maternal/neonatal outcomes between the two groups revealed that the frequency of maternal death in the obstetrical DIC group tended to be higher than in the control group. The frequency of stillbirth in the obstetrical DIC group was significantly higher (p\u0026thinsp;=\u0026thinsp;0.0086) than in the control group.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eUnderlying disease/pathology and laboratory findings\u003c/h2\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the underlying disease/pathology and the laboratory findings of the study cohort. In the obstetrical DIC group, the rate of underlying disease/pathology and levels of FDP and D-Dimer were significantly higher (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) and the level of fibrinogen was significantly lower (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) compared with those in the control group. Notably, the frequency of women with fibrinogen levels\u0026thinsp;\u0026lt;\u0026thinsp;150 mg/dL in the obstetrical DIC group was significantly higher (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) than in the control group. Furthermore, the median platelet count and antithrombin activity were significantly lower (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001 and p\u0026thinsp;=\u0026thinsp;0.0103, respectively) in the obstetrical DIC group than in the control group.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eUnderlying disease/pathology and laboratory findings of participants\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;212)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObstetrical\u003c/p\u003e \u003cp\u003eDIC (n\u0026thinsp;=\u0026thinsp;12)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;200)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eObstetrical DIC scores (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003cp\u003e[0\u0026ndash;10]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u003c/p\u003e \u003cp\u003e[\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;7]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI. Underlying disease/pathology (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;4]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;4]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOne or more\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13 (6.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlacental abruption\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (2.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (2.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0389\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmniotic fluid embolism\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (0.94%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0030\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePostpartum hemorrhage with coagulopathy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (9.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (83.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (4.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eII. Coagulability\u003c/p\u003e \u003cp\u003efinding (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;4]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e[\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;4]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFibrinogen (mg/dL)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e321\u003c/p\u003e \u003cp\u003e[24\u0026ndash;634]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78\u003c/p\u003e \u003cp\u003e[24\u0026ndash;194]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e332\u003c/p\u003e \u003cp\u003e[53\u0026ndash;634]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;150 mg/dL\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19 (9.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11 (91.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (4.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIII. Fibrinolysis\u003c/p\u003e \u003cp\u003efinding (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;2]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e[0\u0026ndash;2]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003cp\u003e[0\u0026ndash;2]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFDP (\u0026micro;g/mL)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22.2\u003c/p\u003e \u003cp\u003e[2.7\u0026ndash;960]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e500\u003c/p\u003e \u003cp\u003e[19.4\u0026ndash;960]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20.5\u003c/p\u003e \u003cp\u003e[2.7\u0026ndash;850]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eD-dimer (\u0026micro;g/mL)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.4\u003c/p\u003e \u003cp\u003e[1.2\u0026ndash;400]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e203\u003c/p\u003e \u003cp\u003e[10.1\u0026ndash;400]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6.8\u003c/p\u003e \u003cp\u003e[1.2\u0026ndash;300]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther laboratory findings\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePlatelets counts\u003c/p\u003e \u003cp\u003e(\u0026times;10\u003csup\u003e9\u003c/sup\u003e/L)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e179\u003c/p\u003e \u003cp\u003e[19\u0026ndash;385]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e113\u003c/p\u003e \u003cp\u003e[19\u0026ndash;150]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e185\u003c/p\u003e \u003cp\u003e[43\u0026ndash;385]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntithrombin activity (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e68.0\u003c/p\u003e \u003cp\u003e[22.9\u0026ndash;104.0]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e45.2\u003c/p\u003e \u003cp\u003e[25.0\u0026ndash;82.0]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e68.8\u003c/p\u003e \u003cp\u003e[22.9\u0026ndash;104.0]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0103\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eObstetrical DIC score\u003c/p\u003e \u003cp\u003e[previous] (points)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e[0\u0026ndash;33]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12\u003c/p\u003e \u003cp\u003e[4\u0026ndash;33]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2\u003c/p\u003e \u003cp\u003e[0\u0026ndash;16]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u0026ge;8 points\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30 (14.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e18 (9.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eDIC; disseminated intravascular coagulation, FDP; fibrin-fibrinogen degradation product\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAll women in the obstetrical DIC group had an obstetrical DIC score (previous criteria)\u0026thinsp;\u0026ge;\u0026thinsp;8 points. The overall obstetrical DIC score (previous criteria) and the frequency of overall obstetrical DIC scores (previous criteria)\u0026thinsp;\u0026ge;\u0026thinsp;8 points in the obstetrical DIC group were significantly higher (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, respectively) than in the control group (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The obstetrical DIC score was significantly correlated with blood loss at delivery and with the levels of fibrinogen, FDP, and D-dimer (all p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001; Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eBlood transfusion and/or blood product therapies\u003c/h2\u003e \u003cp\u003eThe frequencies of transfusions of fresh frozen plasma and red blood cell, platelet, and fibrinogen concentrate in the obstetrical DIC group were significantly higher (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) than those in the control group (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBlood transfusion and/or blood product therapies\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOverall\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;212)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eObstetrical\u003c/p\u003e \u003cp\u003eDIC (n\u0026thinsp;=\u0026thinsp;12)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;200)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eP value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFFPs\u003c/p\u003e \u003cp\u003e(and cryoprecipitate *)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e56 (26.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44 (22.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (units)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;50]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 [4\u0026ndash;50]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;32]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFibrinogen concentrates\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (9.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (83.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (5.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (g)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;12]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 [0\u0026ndash;12]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;6]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRBCs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e86 (40.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (100%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e74 (37.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (units)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;54]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 [14\u0026ndash;54]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;42]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePCs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (5.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (41.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (3.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (units)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;40]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 [0\u0026ndash;40]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;40]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAutologous blood\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (7.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16 (8.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.6058\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (units)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;8]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 [0\u0026ndash;0]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;8]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.3098\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntithrombin products\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (5.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (8.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10 (5.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.4816\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDosage (units)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0 [0\u0026ndash;3000]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 [0\u0026ndash;3000]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0 [0\u0026ndash;3000]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.5791\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eDIC; disseminated intravascular coagulation, FFP; fresh frozen plasma, RBC; red cell concentrates, PC; platelet concentrates.\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e* cryoprecipitates; both group had one woman, respectively.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eComparison of reliability and validity of new criteria (tentative version) with previous criteria\u003c/h2\u003e \u003cp\u003eThere was a significantly positive relationship between the overall obstetrical DIC scores using the new criteria (tentative version) and the overall obstetrical DIC scores using the previous criteria (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003ea). Cronbach alpha was 0.767 and Pearson product-moment correlation coefficient was 0.712 between the new criteria and previous criteria. These findings verified the reliability and validity of the new criteria (tentative version) in comparison with the previous criteria.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe frequency of women with fibrinogen levels\u0026thinsp;\u0026lt;\u0026thinsp;150 mg/dL diagnosed with obstetrical DIC according to the new criteria was significantly higher than in women diagnosed with obstetrical DIC according to the previous criteria (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0006; Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eb).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur study results revealed three key points. First, the new Japanese diagnostic criteria for obstetrical DIC (tentative version) was effective for the diagnosis of obstetrical DIC in women with PPH. Second, almost all women with obstetrical DIC had hypofibrinogenemia. Conversely, almost all women without obstetrical DIC did not have hypofibrinogenemia. Third, a comparison of the new criteria with the obstetrical DIC score (previous criteria) proved the reliability and validity of the new criteria.\u003c/p\u003e \u003cp\u003eThe scoring system of the previous criteria was complicated. There were three significant differences between the previous criteria and the new criteria \u003csup\u003e1\u003c/sup\u003e. First, both criteria had placental abruption and amniotic fluid embolism as underlying diseases. The previous criteria also had DIC type-PPH, eclampsia, and others as underlying diseases, but the new criteria only had PPH with coagulopathy. Second, compared with the previous criteria, the new criteria excluded clinical symptoms. Third, the new criteria did not include all the laboratory findings from the previous criteria (notably platelet count and prothrombin time).\u003c/p\u003e \u003cp\u003eRegarding underlying diseases, the previous criteria did not define DIC type-PPH. In the new criteria, PPH with coagulopathy was defined as massive PPH without blood clots \u003csup\u003e1, 3\u003c/sup\u003e. Thus, it should be checked that the hemorrhage collected in the basin does not form a blood clot. The previous criteria had five categories of clinical symptoms (acute renal failure, acute respiratory failure excluding amniotic fluid embolism, organ failure, hemorrhage diathesis, and shock symptoms), which included a total of 13 factors \u003csup\u003e3\u003c/sup\u003e, and the clinical symptoms were sufficiently specific to effectively diagnose critical obstetric hemorrhage. In contrast, the new criteria are specific to the diagnosis of obstetrical DIC. The platelet count was excluded as a laboratory finding in the new criteria because platelets are involved in primary hemostasis, and fibrinogen was included because it is involved in secondary hemostasis \u003csup\u003e6\u003c/sup\u003e. In the obstetrical DIC, there is a malfunction of not only the primary hemostasis system but also the secondary hemostasis system. If the secondary hemostasis system is compromised, this leads to certain death; thus hypofibrinogenemia and hypercoagulation (high levels of FDP and/or D-dimer) are critical laboratory findings. Therefore, the new criteria consider fibrinogen and FDP/D-dimer levels more important than platelet counts.\u003c/p\u003e \u003cp\u003eOvert DIC is diagnosed worldwide according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) published in 2001 \u003csup\u003e7\u003c/sup\u003e. Erez et. al. published the pregnancy-specific modified ISTH DIC score in 2014 \u003csup\u003e8\u003c/sup\u003e, which included underlying disease and clinical symptoms as factors to diagnose obstetrical DIC (see Supplementary Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e online). The inclusion of underlying diseases as one of the factors in both the previous and new Japanese criteria is a clear departure from the worldwide criteria \u003csup\u003e1\u0026ndash;3\u003c/sup\u003e. Regarding the laboratory findings, the overt DIC diagnostic criteria included platelet count, FDP/D-dimer/soluble fibrin, fibrinogen, and prothrombin time, while the pregnancy-specific modified ISTH DIC score included prothrombin time difference, platelet count, and fibrinogen level. The new Japanese criteria do not include platelet count as one of the factors, which is a clear deviation from the worldwide criteria \u003csup\u003e1\u003c/sup\u003e. Thus, the new Japanese criteria are globally unique.\u003c/p\u003e \u003cp\u003eA retrospective single-center case-control study demonstrated that the new Japanese criteria detected more severe cases of obstetrical DIC that needed treatment with a higher number of transfusions of fresh frozen plasma and/or cryoprecipitate, red blood cell concentrate, and platelet concentrate compared with the pregnancy-specific modified ISTH DIC score \u003csup\u003e9\u003c/sup\u003e. In our study, the new Japanese criteria detected more severe cases of obstetrical DIC compared with the previous obstetrical DIC score. Thus, the frequency of pregnant women diagnosed with obstetrical DIC may decrease in Japan with the use of the new criteria.\u003c/p\u003e \u003cp\u003eThis study had two limitations: the sample size was small and the study design was retrospective, not prospective. Thus, a multicenter prospective study is necessary to confirm our findings.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eWe proved the effectiveness, reliability, and validity of the new Japanese diagnostic criteria for obstetrical DIC (tentative version). Thus, they can be accepted as the final version.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and Setting\u003c/h2\u003e \u003cp\u003eThis retrospective multicenter cohort study was conducted at eight institutions (Aiiku Hospital, Juntendo University Juntendo Hospital, Juntendo University Urayasu Hospital, Kansai Medical University Hospital, Hamamatsu Medical Center, Mie University School of Medicine, Okayama University Hospital, and Saitama Medical University Saitama Medical Center) supported by JSOGNH.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eData were collected from the medical records of pregnant women with massive PPH (blood loss\u0026thinsp;\u0026ge;\u0026thinsp;1,000 mL during vaginal delivery or \u0026ge;\u0026thinsp;2,000 mL during cesarean section), including maternal and neonatal characteristics, underlying diseases, and laboratory test results (fibrinogen and FDP or D-dimer) before and after treatment for obstetrical DIC (transfusion of blood or blood products).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eInclusion and exclusion criteria\u003c/h2\u003e \u003cp\u003eBetween July 2022 and June 2023, 7,744 women with a singleton pregnancy delivered after 22 gestational weeks at the eight predetermined institutions. Those with massive PPH were included in the study cohort. Women who had received a transfusion of blood or blood products at a primary facility prior to being transferred to one of the eight institutions were excluded, as were those with one or more missing laboratory results before receiving blood transfusion at delivery.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eDiagnosis and treatment of obstetrical DIC\u003c/h2\u003e \u003cp\u003eObstetrical DIC was diagnosed at all institutions according to the new criteria for obstetrical DIC (tentative version) (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). All women with obstetrical DIC were treated as per JSOG \u003csup\u003e10\u003c/sup\u003e and JSOGNH recommendations \u003csup\u003e11\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAccording to the previously used Japanese obstetrical DIC score, a total score\u0026thinsp;\u0026ge;\u0026thinsp;8 indicates DIC suspicion and a total score\u0026thinsp;\u0026ge;\u0026thinsp;13 (including\u0026thinsp;\u0026ge;\u0026thinsp;2 points for laboratory findings) confirms DIC (see Supplementary Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e online) \u003csup\u003e2, 3\u003c/sup\u003e. In the present study, we considered an obstetrical DIC score\u0026thinsp;\u0026ge;\u0026thinsp;8 as confirmation of DIC.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eSample size calculation\u003c/h2\u003e \u003cp\u003eAccording to the hypothesis of a study population with the primary outcome as the presence of hypofibrinogenemia (fibrinogen\u0026thinsp;\u0026lt;\u0026thinsp;150 mg/dL), we calculated that the study cohort required four women with obstetrical DIC and 80 women without obstetrical DIC. Thus, the ideal minimum sample size was 49 if the rates of hypofibrinogenemia were 80% among women with obstetrical DIC and 20% among women without obstetrical DIC and the ratio of women with obstetrical DIC to those without obstetrical DIC was 1:20 (rate of obstetrical DIC in women with massive PPH was 5%) with an error level of 0.05 and power of 0.8.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eData were presented as medians (minimum\u0026ndash;maximum) or numbers (%). Statistical analyses were performed using JMP Pro v17.0 (SAS Institute Inc., Cary, NC, USA). We used Tukey\u0026ndash;Kramer honestly significant difference test, Wilcoxon signed rank test, or Mann\u0026ndash;Whitney U test to compare medians (minimum\u0026ndash;maximum) and Fisher exact test to compare categorical variables. P-values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 were considered to indicate statistical significance for all analyses.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eEthics\u003c/h2\u003e \u003cp\u003e This study was conducted in accordance with the principles of the Declaration of Helsinki and approved en bloc for all institutions by the Kansai Medical University Hospital Institutional Review Board (approval no. 2022042; accepted April 24, 2023). All study participants provided informed consent.\u003c/p\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank Enago (www.enago.jp) for the English language review.\u003c/p\u003e\n\u003cp\u003eThe authors thank the Working Group for Revision of Obstetric DIC Score in the Japan Society of Obstetrical, Gynecological and Neonatal Hematology.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: Mamoru Morikawa, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eData curation: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda.\u003c/p\u003e\n\u003cp\u003eFormal analysis: Mamoru Morikawa, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eFunding acquisition: Mamoru Morikawa\u003c/p\u003e\n\u003cp\u003eInvestigation: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda.\u003c/p\u003e\n\u003cp\u003eMethodology: Mamoru Morikawa, Hisashi Masuyama, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eProject administration: Mamoru Morikawa, Hisashi Masuyama, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eResources: Mamoru Morikawa, Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Masafumi Nii, Mariko Serizawa, Jun Takeda.\u003c/p\u003e\n\u003cp\u003eSoftware: Mamoru Morikawa\u003c/p\u003e\n\u003cp\u003eSupervision: Hisashi Masuyama, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eValidation: Mamoru Morikawa, Shigetaka Matsunaga, Shintaro Makino, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eVisualization: Mamoru Morikawa, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003eWriting\u0026ndash;original draft: Mamoru Morikawa\u003c/p\u003e\n\u003cp\u003eWriting\u0026ndash;review \u0026amp; editing: Yoshiharu Takeda, Shigetaka Matsunaga, Shintaro Makino, Eriko Eto, Mariko Serizawa, Masafumi Nii, Jun Takeda, Hisashi Masuyama, Atsuo Itakura\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics declaration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved en bloc for all institutions by the Kansai Medical University Hospital Institutional Review Board (approval no. 2022042; accepted April 24, 2023). All study participants provided informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional Information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFinancial disclosure statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe first author (Mamoru Morikawa) received funding for this work from Japan Blood Products Organization (Tokyo, Japan. URL: https://www.jbpo.or.jp/english/).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eItakura, A., et al. Disseminated intravascular coagulation (DIC) in obstetrics field: diagnostic criteria for obstetrical DIC (Tentative version). Jpn. J. Obstet. Gynecol. Neonatal. Hematol.32, 43\u0026ndash;49 (2023).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMaki, M., Terao, T,, Ikenoue, K. Obstetrical DIC score. Obstet. Gynecol. Therapy. 50,119\u0026ndash;124 (1985).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKobayashi, T. Obstetrical disseminated intravascular coagulation score. J. Obstet. Gynaecol. Res. 40, 1500\u0026ndash;1506 (2014).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMorikawa, M., Nii, M., Nakabayashi, Y., Itakura, A., Kobayashi, T., Adachi, T. Capacity of Japanese institutions to manage obstetrical disseminated intravascular coagulation in 2018: A national surveillance questionnaire and retrospective cohort study. J. Obstet. Gynaecol. Res. 47 3159\u0026ndash;3170 (2021).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMorikawa, M., et al. Effect of hypofibrinogenemia on obstetrical disseminated intravascular coagulation in Japan in 2018: a multicenter retrospective cohort study. Int. J. Hematol. 114, 18\u0026ndash;34 (2021).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWinter, W.E., Flax, S.D., Harris, N.S. Coagulation testing in the core laboratory. Lab Med. 48, 295\u0026ndash;313 (2017).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTaylor, F.B. Jr., Toh, C.H., Hoots, W.K., Wada, H., Levi, M. Scientific subcommittee on disseminated intravascular coagulation (DIC) of the International Society on Thrombosis and Hemostasis (ISTH). Towards definition, clinical and laboratory criteria, and a scoring system for disseminated intravascular coagulation. Thromb Haemost. 86, 1327\u0026ndash;1330 (2001).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eErez, O., et al. DIC score in pregnant women\u0026ndash;a population based modification of the International Society on thrombosis and hemostasis score. PLoS One. 9, e93240 (2014).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMorikawa, M., Kamiya, A., Yoshida, A., Nishibata, S., Okada, H. Differences between Japanese new criteria and pregnancy-specific modified ISTH DIC scores for obstetrical DIC diagnosis. Int. J. Hematol. 119, 265\u0026ndash;274.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eItakura, A., et al. Guidelines for obstetrical practice in Japan: Japan Society of Obstetrics and Gynecology and Japan Association of Obstetricians and Gynecologists 2020 edition. J. Obstet. Gynaecol. Res. 49,5\u0026ndash;53 (2023).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKobayashi, T., Terao, T., Maki, M., Ikenoue, T. Diagnosis and management of acute obstetrical DIC. Semin. Thromb. Hemost. 27, 161\u0026ndash;167 (2001).\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"criteria, obstetrical disseminated intravascular coagulation, tentative version, reliability, validity","lastPublishedDoi":"10.21203/rs.3.rs-4416217/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4416217/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eSince July 2023, obstetrical disseminated intravascular coagulation (DIC) in Japan has been diagnosed based on the new criteria (tentative version), which assesses the main underlying disease, fibrinogen level, and fibrin/fibrinogen degradation products or D-dimer level. The previous Japanese criteria assessed underlying disease, clinical symptoms, and various laboratory findings. This study aimed to prove the effectiveness, reliability, and validity of the new criteria. We analyzed 212 women with singleton pregnancies who delivered after 22 gestational weeks and experienced blood loss\u0026thinsp;\u0026ge;\u0026thinsp;1,000 mL during vaginal delivery or \u0026ge;\u0026thinsp;2,000 mL during cesarean section. Those with missing laboratory findings before receiving blood transfusion at delivery were excluded. In the obstetrical DIC group, the frequency of fibrinogen levels\u0026thinsp;\u0026lt;\u0026thinsp;150 mg/dL was significantly higher than in the control group (92% vs 4%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), as was the frequency of scores\u0026thinsp;\u0026ge;\u0026thinsp;8 according to the previous Japanese criteria (100% vs. 9%, p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). The relationship between the overall scores using the new criteria with those using the previous criteria was significantly positive (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). Cronbach alpha was 0.767 and Pearson product-moment correlation coefficient was 0.712 between the new and previous criteria. In conclusion, we proved the effectiveness, reliability, and validity of the Japanese new criteria.\u003c/p\u003e","manuscriptTitle":"Effectiveness, reliability, and validity of new Japanese diagnostic criteria for obstetrical disseminated intravascular coagulation (tentative version): A retrospective multicenter study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-24 08:49:16","doi":"10.21203/rs.3.rs-4416217/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-05T09:44:43+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-06-04T03:49:27+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-29T05:53:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"259398107536104403999402542361034718291","date":"2024-05-20T06:26:36+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-19T12:00:12+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"115893674437639200056674469663973862599","date":"2024-05-19T05:41:14+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"288536206651287802973480695185226326500","date":"2024-05-19T04:30:38+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-05-19T02:35:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-05-19T02:29:48+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-05-15T18:24:02+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-05-15T14:07:36+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2024-05-14T03:35:47+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3622c81e-3427-4fd6-b741-a21f9e658169","owner":[],"postedDate":"May 24th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":32159393,"name":"Health sciences/Health care/Diagnosis/Physical examination"},{"id":32159394,"name":"Health sciences/Biomarkers/Diagnostic markers"}],"tags":[],"updatedAt":"2024-08-05T16:06:57+00:00","versionOfRecord":{"articleIdentity":"rs-4416217","link":"https://doi.org/10.1038/s41598-024-68298-7","journal":{"identity":"scientific-reports","isVorOnly":false,"title":"Scientific Reports"},"publishedOn":"2024-07-30 15:58:14","publishedOnDateReadable":"July 30th, 2024"},"versionCreatedAt":"2024-05-24 08:49:16","video":"","vorDoi":"10.1038/s41598-024-68298-7","vorDoiUrl":"https://doi.org/10.1038/s41598-024-68298-7","workflowStages":[]},"version":"v1","identity":"rs-4416217","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4416217","identity":"rs-4416217","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}