Efficacy of early versus later intrauterine balloon tamponade to treat postpartum haemorrhage after vaginal delivery among women with moderate bleeding (500-1000mL): exploratory analysis from a randomized clinical trial

Efficacy of early versus later intrauterine balloon tamponade to treat postpartum haemorrhage after vaginal delivery among women with moderate bleeding (500-1000mL): exploratory analysis from a randomized clinical trial | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL BJOG: An International Journal of Obstetrics and Gynaecology This is a preprint and has not been peer reviewed. Data may be preliminary. 4 August 2025 V1 Latest version Share on Efficacy of early versus later intrauterine balloon tamponade to treat postpartum haemorrhage after vaginal delivery among women with moderate bleeding (500-1000mL): exploratory analysis from a randomized clinical trial Authors : Anne-Sophie Boucherie [email protected] , Anne ROUSSEAU 0000-0002-2578-0512 , Patrick Rozenberg 0000-0002-8566-015X , Catherine Deneux-Tharaux 0000-0002-6561-3321 , and Thibaud Quibel Authors Info & Affiliations https://doi.org/10.22541/au.175429653.39391023/v1 205 views 172 downloads Contents Abstract Introduction Methods Results Discussion Conclusion Figure legend Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Objective A randomised controlled trial found no significant reduction in the rate of severe postpartum haemorrhage, defined as blood loss of 1000 mL or more, or transfusion of three or more units of packed red blood cells, when an intrauterine balloon tamponade and second-line uterotonics were used simultaneously compared with using the balloon after failure of second-line uterotonics. However, one quarter of the participants had already lost more than 1000 mL at the time of randomisation, increasing heterogeneity and coagulopathy risk. This may have obscured a potential benefit in women with moderate bleeding (500–1000 mL). We aimed to assess the effect of early versus later balloon use in this subgroup. Design Exploratory analysis of a randomised controlled trial. Setting Maternity units across France. Population Women with 500–1000 mL of blood loss at the time of second-line uterotonic administration after vaginal delivery (n = 264). Methods Outcomes were compared between women randomised to early intrauterine balloon tamponade (n = 128) and those who received balloon after failure of second-line uterotonics (n = 136). Risk ratios were estimated using multivariate Poisson regression with robust variance. Main Outcome Measures Severe postpartum haemorrhage (≥3 packed red blood cell units and/or total blood loss >1000 mL). Results Severe postpartum haemorrhage occurred in 57.8% of the early group and 70.6% of the latter group (adjusted risk ratio 0.83; 95% CI 0.68–1.01; P = 0.06). Conclusions Early balloon tamponade did not significantly reduce the rate of severe haemorrhage among women with moderate bleeding. Anne-Sophie Boucherie 1,2 , Anne Rousseau 2 Patrick Rozenberg 2,3 Catherine Deneux-Tharaux 4 Thibaud Quibel 1,2 1 Department of Obstetrics and Gynaecology, Poissy-Saint Germain Hospital, Poissy, France 2 Paris Saclay University, UVSQ, Inserm, Team U1018, Clinical Epidemiology, CESP, Villejuif, France 3 Department of Obstetrics and Gynaecology, American Hospital of Paris, Neuilly s/Seine, Paris, France 4 Obstetrical, Perinatal and Pediatric Life Course Epidemiology (OPPALE Team), Centre de Recherche Epidémiologie et Statistiques (CRESS), INSERM, INRAE, Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. Correspondence : Anne-Sophie Boucherie Department of Obstetrics and Gynaecology, Poissy Saint Germain Hospital 10 rue du champ gaillard, 78300 Poissy, France E-mail : [email protected] Shortened running title Efficacity of early versus later intrauterine balloon tamponade Conflicts of interest the authors report no potential conflicts of interest. Author contributions ASB : Conceptualization, methodology, formal analysis, writing – original draft. AR : Methodology, writing – reviewing and editing. CDT: Conceptualization, writing – reviewing and editing. PR : Conceptualization, writing – reviewing and editing. TQ : Methodology, writing – reviewing and editing, supervision. Role of the funding source The TUB trial was funded by a research grant from the French Ministry of Health (PHRC R 12139) and sponsored by the Department de la Recherche Clinique et du Developpement de l’Assistance Publique-Hopitaux de Paris. This analysis has not received any specific funding. Word count : 2612 ABSTRACT Word count : 249 Objective A randomised controlled trial found no significant reduction in the rate of severe postpartum haemorrhage, defined as blood loss of 1000 mL or more, or transfusion of three or more units of packed red blood cells, when an intrauterine balloon tamponade and second-line uterotonics were used simultaneously compared with using the balloon after failure of second-line uterotonics. However, one quarter of the participants had already lost more than 1000 mL at the time of randomisation, increasing heterogeneity and coagulopathy risk. This may have obscured a potential benefit in women with moderate bleeding (500–1000 mL). We aimed to assess the effect of early versus later balloon use in this subgroup. Design Exploratory analysis of a randomised controlled trial. Setting Maternity units across France. Population Women with 500–1000 mL of blood loss at the time of second-line uterotonic administration after vaginal delivery (n = 264). Methods Outcomes were compared between women randomised to early intrauterine balloon tamponade (n = 128) and those who received balloon after failure of second-line uterotonics (n = 136). Risk ratios were estimated using multivariate Poisson regression with robust variance. Main Outcome Measures Severe postpartum haemorrhage (≥3 packed red blood cell units and/or total blood loss >1000 mL). Results Severe postpartum haemorrhage occurred in 57.8% of the early group and 70.6% of the latter group (adjusted risk ratio 0.83; 95% CI 0.68–1.01; P = 0.06). Conclusions Early balloon tamponade did not significantly reduce the rate of severe haemorrhage among women with moderate bleeding. Keywords intrauterine balloon tamponade, postpartum haemorrhage, transfusion, uterotonics, vaginal delivery, prostaglandins Introduction Postpartum haemorrhage (PPH) remains a major cause of maternal morbidity and mortality worldwide (1–4). The first-line treatment is uterotonic drugs such as oxytocin and/or prostaglandins.(5) If bleeding continues, second-line invasive therapies like pelvic arterial embolization, arterial ligation, and uterine compression sutures may be considered. Finally, hysterectomy is the ultimate life-saving procedure for massive bleeding.(5–7) In the past decade, intrauterine balloon tamponade (IUBT) has become a recommended alternative to invasive therapies in the management of PPH refractory to uterotonics.(5,6,8) Its effectiveness— defined as successful control of bleeding without the need for additional interventions—has been evaluated in observational studies,(9–15) and was estimated at ~87.1% (95% confidence interval [CI], 84.1–89.8%) after vaginal delivery in a recent meta-analysis.(16) However, optimal timing of its use remains controversial. Observational cohort studies have shown that balloon failure is associated with blood loss severity at insertion, possibly due to development of coagulopathy in cases of massive haemorrhage.(10,17–20). The multicentric randomized TUB trial was recently conducted to assess the optimal timing of IUBT use following second-line uterotonics administration(21). That study compared the effect of early versus later use of IUBT on the rate of severe PPH. Among the 403 participants, early use of IUBT, that is, performed at the same time as the second-line uterotonic treatment, did not significantly reduce the proportion of women requiring at least three units of packed red blood cells (RBCs) and/or experiencing total calculated peripartum blood loss >1000 mL compared with later use, that is, after the failure of second-line uterotonic treatment and before recourse to invasive procedures. However, the study population was heterogeneous, including women with moderate (blood loss from 500–1000 mL) and severe (>1000 mL) PPH at the time of randomization. More than a quarter (28.0%) had already lost over 1000 mL of blood at the time of second-line uterotonics administration, increasing their risk of balloon failure and coagulopathy. The presence of women with severe PPH may have masked any potential benefit of early use of in those with moderate blood loss. To address this limitation, this secondary analysis aimed to evaluate the effect of early use IUBT - when used at the same time as the second-line uterotonic treatment - versus later, when used only after failure of second-line uterotonics, on the rate of severe PPH, specifically among women with moderate blood loss (500–1000 mL) at the time of second-line uterotonic administration. Methods Study design This study was an exploratory analysis of a randomized clinical trial – the TUB trial, the methodology of which has been described.(21) Briefly, the trial took place in France and included 403 women with PPH refractory to oxytocin infusion after vaginal delivery. PPH management followed French national guidelines. (5) Prevention relied on prophylactic administration of 5–10 IU of oxytocin IV at delivery and early detection of blood loss using a graduated collection drape placed under the patient. Active management of PPH included bladder catheterisation, manual uterine exploration, an additional 10 IU of oxytocin IV, uterine massage, and repair of genital tract lesions. If bleeding persisted 15 minutes later, an IV infusion of sulprostone (prostaglandin E₂) was initiated. No other uterotonics are recommended in France. In the TUB trial, women were informed during pregnancy and gave consent to participate during the management of the haemorrhage. They were randomized in a 1:1 ratio to either the intervention group — in which the standard sulprostone (prostaglandin E2) infusion was combined with intrauterine balloon tamponade (IUBT) — or the control group, in which sulprostone alone was initiated and IUBT was performed only in cases of persistent bleeding after ≥30 minutes of sulprostone administration. In both groups, if bleeding persisted for 30 minutes after IUBT insertion, an emergency invasive radiological or surgical procedure was performed. For this study, only women from the TUB trial who had quantified blood loss 500-1000mL at the time of sulprostone (prostaglandin E2) infusion were included. A graduated collector bag was placed immediately after delivery and left in place until the birth attendant considered that bleeding had ceased. Women with missing quantified blood loss data at the time of second-line uterotonics administration were excluded from analyses. Study outcomes The primary outcome herein was the same as the TUB trial: the proportion of women with severe PPH, defined as receiving at ≥3 units of packed RBCs and/or having a calculated peripartum blood loss >1000 mL. Secondary outcomes included the proportion of women meeting each component of the primary outcome separately; the mean total calculated peripartum blood loss; the proportion of women with calculated blood loss ≥1500 mL; the proportion of women receiving any RBC transfusion; the difference in haematocrit levels before delivery and on the second postpartum day; the difference in haemoglobin levels before delivery and on the second postpartum day; the proportion of women with a peripartum haemoglobin drop ≥4 g/dL; the proportion of women requiring invasive second-line therapies (e.g., arterial embolization, pelvic arterial ligation, uterine compression sutures, hysterectomy); and the proportion of women who died after delivery. Maternal age was categorized as <35 or ≥35 years. Obesity was defined as a body mass index (BMI) ≥30 kg/m 2 . Maternal region of birth was divided into three groups: Europe, Sub-Saharan Africa, and other. Statistical analysis Because this was an exploratory analysis and randomization was not performed among this selected subgroup of women, we first compared baseline general and pregnancy characteristics and management of labour and haemorrhage between the two groups. Categorial variables were expressed as values and percentages and were compared using Pearson Χ 2 test or Fisher’s exact probability test, as appropriate. Continuous variables were expressed as mean ± standard deviation and were compared using Student’s t test. Effects of early IUBT were expressed as risk ratio (RR) with 95% CI for categorical outcomes, estimated with Poisson regression models with robust variance, and as mean differences with 95% CIs for continuous outcomes, estimated with general linear models. Adjusted variables were selected based on the literature and univariate analyses (≤ 0.20). As the proportion of women with at least one missing value was only 2.2%, we performed all analyses with complete data. We also performed all analyses in a per-protocol population, excluding women in the study group who had IUBT insertion >15 minutes after second-line uterotonics administration and women in the control group who had IUBT insertion <30 minutes after second-line uterotonics administration. All tests were two-tailed and P <.05 was considered statistically significant. All analyses were performed using R software (version 4.0.3; R foundation for Statistical Computing, Vienna, Austria). Results Intention-to-treat groups Among the 403 original participants, 264 women (68.0%) were included as quantified blood loss was measured between 500 – 1000 mL at second-line uterotonics treatment (Figure 1). Among this population, 128 received early IUBT, combined with second-line uterotonics treatment and 136 received later IUBT, after second-line uterotonics failure (control group). There were no statistically significant between-group differences on baseline characteristics or labour management (Table 1). Quantified blood loss at the initiation of haemorrhage management was 485 mL (±167) in the intervention group and 506 mL (±156) in the control group ( P =.30). There were no statistically significant between-group differences in initial haemorrhage management (Table 2). Quantified blood loss volume at second-line uterotonics administration was 739 mL (±183 mL) in the intervention group and 749 mL (±177 mL) in the control group ( P =.60). Mean time to second-line uterotonics administration was 31 (±22) minutes in the intervention group and 30 (±28) minutes in the control group ( P =.70). In the intervention group, all but one woman had IUBT (127/128, 99.2%). Balloon insertion was performed within 15 minutes of second-line uterotonics administration for 106 women (106/128, 82.8%). In the control group, second-line uterotonics successfully controlled bleeding in 107 women (78.7%), while the remaining 29 patients (21.3%) required intrauterine balloon tamponade due to persistent bleeding despite uterotonic treatment. Among these, nine had IUBT within 30 minutes after second-line uterotonics administration. Outcomes The proportion of women who received ≥3 packed RBC units for haemorrhage treatment and/or had a calculated total blood loss volume compared with the control group (57.8% [74/128] versus 70.6% [96/136]; crude RR, 0.82; 95% CI, 0.68–0.98; P =.03). After adjustment for obesity, maternal region of birth, multiple pregnancy, labour induction, oxytocin infusion during labour and episiotomy the difference in the frequency of the primary outcome was not significant between women with PPH and an early IUBT, that is performed at the same time as the second-line uterotonic treatment, and women with a later IUBT use, that is performed after the second-line uterotonic treatment failure (adjusted RR, 0.83; 95% CI, 0.87–1.01; P =.06). After haemorrhage management, mean total quantified blood loss was 991 mL (±343) in the intervention group and 997 mL (±682) in the control group ( P =.90) and there were no significant between-group differences in the rates of any secondary outcome (Table 3). No maternal deaths were reported. The rate of any RBC transfusion was similar between the intervention and control groups (15.6% [20/128] and 16.2% [22/136], respectively; adjusted RR, 1.04, 95% CI, 0.59–1.83; P =.89). The rate of invasive procedures was 3.0% overall, including pelvic arterial ligation (0.0% [0/128] and 0.1% [1/136], respectively), uterine compression suture (0.0% and 0.0%, respectively), arterial embolization (3.2% [4/128] and 2.6% [3/136], respectively) and hysterectomy (0.0% [0/128] and 0.1% [1/136], respectively) (Table 3). Per-protocol analysis The per-protocol population included 233 participants: 106 who received IUBT within 15 minutes of second-line uterotonics treatment (intervention group), and 127 who either did not receive IUBT or received it ≥30 minutes after second-line uterotonics treatment (control group) (Figure 1). Baseline characteristics, labour management, and haemorrhage management were similar between these groups (Table 4). The incidence of severe PPH was not reduced in the early versus later use of IUBT on this per-protocol population (Table 5). Discussion Main findings In this secondary TUB trial analysis of the subgroup of women with moderate PPH (500-1000ml) at second-line uterotonics administration, the incidence of severe PPH was not reduced in the group with early IUBT use compared with later use after second-line uterotonics failure and before recourse to an invasive procedure. Moreover, rates of RBC transfusion, calculated total blood loss, and surgical procedures were similar between the groups. These results were consistent between the intention-to-treat and per-protocol analyses. Interpretation Diagnostic thresholds for PPH vary across international recommendations. According to the World Health Organization and French recommendations, PPH is blood loss ≥500 mL within 24 hours after vaginal delivery, even if its occurrence is well tolerated and does not lead to severe morbidity.(5,8) This threshold encourages early PPH diagnosis, facilitating prompt haemorrhage management because bleeding severity is time sensitive.(22) Herein, PPH was diagnosed and managed at an early stage, with median blood loss of 500 mL. Second-line uterotonics – sulprostone (PGE2) - were also administered early, with a median blood loss of 750 mL. Our study was also conducted in referral hospitals with round-the-clock on-site trained obstetricians and anaesthesiologists. IUBT was effective herein in >95% of cases, beyond that expected based on a recent meta-analysis, resulting in a moderate rate of total calculated blood loss (<1000 mL) and a very low incidence of morbidities, such as transfusion and invasive procedures ( i.e., arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy). We did not find a statistically significant reduction in the rate of severe PPH from early IUBT use, possibly due to lack of statistical power, as shown by the unchanged RR between our two analysis approaches and their CIs. However, any benefits from early IUBT use are likely modest, evidenced herein by the lack of reduced transfusion rates, calculated blood loss, and surgical procedures between the groups. Prompt, aggressive haemorrhage management in our sample may also explain the modest benefits. Therefore, in the absence of a clear argument about the best timing for IUBT use, a conservative approach of sequential IUBT after second-line uterotonics failure is a reasonable approach, if haemorrhage is managed aggressively and promptly. A sample of women with severe PPH (>1000 mL) before onset of second-line uterotonics may have shown different conclusions. Unfortunately, this question cannot be addressed because of the high incidence of protocol violations in the TUB trial. Indeed, in the control group, a high proportion of women received early IUBT after second-line uterotonics administration in this sample, reducing the contrast between the two arms. Our study also provides insight into prostaglandin efficacy. Unlike oxytocin, which was evaluated in a Cochrane review,(23) we lack robust, current data on second-line uterotonics. This knowledge gap has led to differences among national societies’ recommended second-line uterotonic treatments.(8) Herein, as in the original TUB trial, 80% of women stopped bleeding after prostaglandin administration. Schmitz also reported an 87% bleeding stop rate post-prostaglandin in women with PPH after vaginal delivery in a large French population-based cohort of 146,781 deliveries from to 2004 to 2006.(24) Clinical and research implications Although PPH continues to be a frequent obstetric event, which carries risks of severe maternal morbidity and mortality, the level of evidence for various treatments is moderate due to the retrospective nature of studies and their heterogeneous populations. The original TUB study is one of few with a high level of evidence for assessing IUBT efficacy, which we hope will prompt further well-designed trials.(21) Although randomized controlled trials help reduce biases and confounding factors in intervention studies, evaluating the efficacy of specific haemorrhage treatments remains extremely difficult. Indeed, haemorrhage interventions are complex because the final outcome (e.g., total blood loss, RBC transfusions, the need for invasive procedures) results from multidimensional determinants that are likely to interact, including resuscitation procedures, human factors, and organizational policies.(22,25,26) Therefore, these interrelated factors need to be standardized, recorded, and collected to allow more reliable interpretation of study results. Given the emergence of innovative devices, studies comparing IUBT and suction devices are also needed(27). Medico economic analyses would be useful complements to efficacy analyses, as some of the current suction devices are very expensive. Finally, although fertility data after IUBT appear reassuring, studies based on larger series are also needed.(28) Strengths and Weaknesses Our data are from a large, robust, multicentre randomized trial. Confidence in our results is bolstered by consistency between our intention-to-treat and per-protocol analyses. Calculated blood loss, the primary outcome, is an objective, validated method. Unlike quantified blood loss, which is subject to investigator detection bias, calculated blood loss is based on objective parameters: pre- and postpartum haematocrits and pre-pregnancy weight. However, Madar et al. found that quantified and calculated blood losses are moderately correlated, and that the difference between them increases with blood loss(29). Our study was not without limitations. Weak and imbalanced recruitment at some centres disallowed multilevel regression models with centre as a random intercept to account for this variance. The primary outcome was not significant. As our analysis was secondary based on a randomized trial, we likely did not have sufficient statistical power to demonstrate a significant difference. With 80% power, a 5% alpha level, and group sizes of 128 and 136 patients, the minimum detectable difference in the rate of severe PPH was approximately 14.2 percentage points. Given the observed severe PPH rate of 70.6% (96/136) in the control group, the intervention group would need to have a severe PPH rate below 56.4% to achieve statistical significance. However, any benefit of early IUBT use is likely modest, as transfusion rates, calculated total blood loss, and second-line therapies did not differ between the groups. Conclusion Among women with PPH from 500–1000 mL at the time of second-line uterotonics administration after vaginal delivery, use of IUBT combined with second-line uterotonics, did not result in reduced incidence of severe PPH compared with its later use after second-line uterotonics failure. Based on these findings, later IUBT use is a reasonable approach treating this patient population. DISCLORE OF INTEREST Author contributions CDT and PR conceptualised and developed the methodology for the TUB trial. ASB, AR and TQ designed the study question and analytic plan. ASB conducted data analysis, generated the tables and figures and drafted the paper. PR, CDT, AR and TQ provided analytic oversight and edited the paper. All authors have read and agreed to the final version of the paper. Funding information None for this analysis. The TUB trial was funded by a research grant from the French Ministry of Health (PHRC R 12139) and sponsored by the Department de la Recherche Clinique et du Developpement de l’Assistance Publique-Hopitaux de Paris. This analysis has not received any specific funding. Conflict of interest statement The authors report no conflict of interest Data availabitily statement Data sharing requests will be considered by the management group upon written request to the corresponding autho Ethics approval The source population included women who participated in the TUB randomised controlled trial ( ClinicalTrials.gov number NCT02226731), approved by the ethics committee of Poissy Saint-Germain Hospital (Comité de Protection des Personnes, Ile de France XI). Participant baseline and labour management characteristics Maternal age at delivery >35 (y) 32 (25.0) 31 (22.7) .70 Mother region of birth .14 Europe 66 (51.6) 83 (61.0) Sub-Saharan Africa 24 (18.8) 15 (11.0) Other 37 (28.9) 35 (25.7) BMI ≥30 kg/m 2 18 (14.1) 13 (9.6) .20 Parity .70 Primiparous 60 (47.0) 63 (46.3) Parous without previous caesarean delivery 62 (46.7) 63 (46.3) Parous with previous caesarean delivery 6 (4.7) 10 (7.4) History of PPH among paras 21 (16.4) 24 (17.6) .80 Multiple pregnancy 10 (7.8) 20 (14.7) .08 Gestational diabetes 20 (15.6) 23 (16.9) .80 Gestational hypertensive disorder 6 (4.7) 7 (5.1) .90 Thrombocytopenia (platelet count <80,000/mm 3 ) 5 (3.9) 3 (2.2) .50 Epidural analgesia 116 (90.6) 124 (91.2) .90 Labor induction 55 (42.9) 48 (35.3) .20 Oxytocin administration during labor 57 (44.5) 74 (54.4) .12 Prophylactic oxytocin administration at delivery 119 (92.9) 128 (94.1) .50 Instrumental delivery 26 (20.3) 32 (23.5) .50 Third- and fourth-degree perineal tears 1 (0.8) 1 (0.7) >.9 Episiotomy 16 (12.5) 24 (17.4) .20 Macrosomia >4000 g 11 (8.6) 17 (12.5) .30 Data are presented as number (percentage) BMI, body mass index; PPH, postpartum hemorrhage TABLE 2 PPH management before second-line uterotonics administration Interval from delivery to PPH diagnosis (min) 47 (60) 29 (16–50) 41 (42) 27 (17–44) .30 Interval from PPH diagnosis to second-line uterotonics administration (min) 31 (22) 25 (17–38) 30 (28) 22 (15–34) .70 Blood loss at PPH diagnosis (mL) 485 (167) 500 (400–505) 506 (156) 500 (400–600) .30 Blood loss at second-line uterotonics administration (mL) 739 (183) 750 (600–850) 749 (177) 750 (629–900) .60 Data are presented as mean (standard deviation) and median (interquartile) PPH, postpartum hemorrhage TABLE 3 Primary and secondary outcomes, and adverse events Primary outcome 74 (57.8%) 96 (70.6%) −13 (−25– −0.54) 0.82 (0.68–0.98) 0.83 (0.69–1.01) .06 Calculated peripartum blood loss >1000 mL 74 (57.8%) 96 (70.6%) −13 (−25– −0.54) 0.82 (0.68–0.98) 0.83 (0.69–1.01) .06 Transfusion of ≥3 units RBCs 4 (3.1%) 8 (5.9%) −2.8 (–8.5–3.0) 0.53 (0.16–1.72) 0.90 (0.25–3.26) .88 Total calculated peripartum blood loss (mL) 1362 (1007) 1432 (1194) −71 (−338–197) - 12 (6217–241) .99 Calculated peripartum blood loss ≥1500 mL 46 (35.9%) 49 (36.0%) −0.09 (−12–12) 0.99 (0.72–1.38) 1.04 (0.75–1.44) .82 Any RBC transfusion 20 (15.6%) 22 (16.2%) −0.55 (−9.9–8.8) 0.97 (0.55–1.68) 1.04 (0.59–1.83) .89 Peripartum change in haemoglobin level (g/dL) 2.81 (1.90) 3.01 (2.39) −0.2 (−0.72–0.32) - 0.02 (−0.45–0.49) .99 Peripartum change in haemoglobin = 4 g/dL 29 (22.6%) 31 (22.8%) −0.14 (−10–10) 0.99 (0.64-1.56) 1.02 (0.76–1.35) .92 Peripartum change in haematocrit level (percentage points) 8.5 (5.8) 9.0 (7.1) −0.58 (−2.1–1.0) - 0.07 (−1.3–1.5) .99 Invasive procedure for PPH 4 (3.1%) 4 (2.9%) 0.18 (−4.1–4.5) 1.06 (0.27–4.16) 1.45 (0.29–7.19) .65 Data are presented as numbers (percentage) or mean (standard deviation) a Between-group differences reported as percentage points; MD in unit of the mean values; b adjusted RRs and adjusted MDs were estimated by multivariate Poisson regression models and general linear model, respectively, with adjustment for maternal country of birth, obesity, multiple pregnancy, labor induction, and use of oxytocin for labor augmentation; c P values for adjusted RR or MD. CI, confidence interval; RBC, red blood cell; RR, risk ratio; MD, mean difference. Figure legend FIGURE 1 Flow chart Supplementary Material File (supplement_bjog.docx) Download 31.02 KB Information & Authors Information Version history V1 Version 1 04 August 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Collection BJOG: An International Journal of Obstetrics and Gynaecology Keywords cin: epidemiology general obstetrics maternal mortality obstetric haemorrhage Authors Affiliations Anne-Sophie Boucherie [email protected] CHI Poissy-Saint-Germain-en-Laye Site Hospitalier de Poissy View all articles by this author Anne ROUSSEAU 0000-0002-2578-0512 Centre de Recherche en Epidemiologie et Sante des Populations View all articles by this author Patrick Rozenberg 0000-0002-8566-015X Centre de Recherche en Epidemiologie et Sante des Populations View all articles by this author Catherine Deneux-Tharaux 0000-0002-6561-3321 Centre de Recherche en Epidemiologie et Statistiques Equipe de Recherche en Epidemiologie Obstetricale Perinatale et Pediatrique View all articles by this author Thibaud Quibel CHI Poissy-Saint-Germain-en-Laye Site Hospitalier de Poissy View all articles by this author Metrics & Citations Metrics Article Usage 205 views 172 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Anne-Sophie Boucherie, Anne ROUSSEAU, Patrick Rozenberg, et al. Efficacy of early versus later intrauterine balloon tamponade to treat postpartum haemorrhage after vaginal delivery among women with moderate bleeding (500-1000mL): exploratory analysis from a randomized clinical trial. Authorea . 04 August 2025. DOI: https://doi.org/10.22541/au.175429653.39391023/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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