A Randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in low middle income countries

A Randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in low middle income countries | 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 Research Article A Randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in low middle income countries Anusha Reddy, Shiny nirupama, Arathy Raj, Richa Sasmita Tirkey Sasmita Tirkey, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3818749/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective The aim of the study is to see if single ultrasound scan in the early third trimester could identify women who need frequent visits for strict glycemic control and the impact on neonatal and maternal outcomes in clinical practice.We decided not to look at serial ultrasounds to detect accelerated growth as it would be expensive, time consuming and difficult to replicate in normal practice. Methods The study was a randomized controlled trial, conducted at Christian Medical College and Hospital(CMCH), a tertiary hospital in south India. The study population was recruited from women who visited antenatal outpatient clinic in the department of Obstetrics and Gynaecology, CMCH, Vellore between May 2019 to September 2021 Results 588 women were included in the study. Outcomes between conventional and ultrasound subgroups ( Standard + ultrasound subgroup with AC ≤ 70 th centile vs ultrasound subgroup AC ≥ 70 th centile)showed significant difference in outcomes.Ultrasound subgroup with AC ≥ 70 th centile had macrosomia(3.59% vs26.67%, P < 0.001),increased severity of diabetes(2.97% vs 16.67%, P < 0.001), 3 rd and 4 th degree perineal tear(2.95% vs 27.27%, P < 0.001) . Conclusion Thus in conclusion this small well designed study did not show any advantage with USGR as compared to the pragmatic simple standard regime, in treatment of women with GDM. gestational diabetes ultrasound standard macrosomia glycemic control Figures Figure 1 Synopsis This study was to compare a pragmatic standard management of GDM with ultrasound guided management to prevent neonatal complications to ensure optimal antenatal care. The study was registered with the Clinical Trials Registry of India(https://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=29575&EncHid=16049.63369&modid=1&compid=19%27,%2729575det%27)with the registration number (CTRI/2019/01/017130). INTRODUCTION The HAPO study [ 1 ] showed a continuum in increase or decrease of fetal weight that was directly proportionate to the maternal blood glucose levels. The revised diagnostic criteria that evolved from the research[ 2 ] doubled the prevalence of women with gestational diabetes (GDM)[ 3 ] and therefore increased the burden on health services. Moreover two large randomized controlled trials [ 4 , 5 ]confirmed the benefits of treating mild to moderate hyperglycaemia. Treatment of GDM involves, increased number of antenatal visits to ensure good glycaemic control, which is the hallmark of optimal management of GDM. Ambulatory home blood glucose monitoring for newly diagnosed GDM that is often cured after delivery, is not popular with the woman and the care provider in under resourced countries, where patients compliance to treatment is a major concern. Most women with mild to moderate GDM can be treated with minor modifications in diet, but identifying women that need close surveillance is often a challenge. The guidelines advocated by major international bodies [ 6 , 7 ] on the frequency of visits and foetal surveillance is not based on good research. Ultrasound has been used to guide therapy but its use in the management of GDM has been used indiscriminately due to paucity of information[ 8 ] Some studies have shown that ultrasound has the potential to identify fetuses that can have neonatal complications[ 9 – 13 ] The use of ultrasound to guide the number of antenatal visits for adequate glycaemic control has not been researched adequately. There is also a need to contrive antenatal care strategies that can obtain optimal neonatal outcomes without burdening the health system in LMIC. Therefore, the aim of our study was to compare a pragmatic standard management of GDM with ultrasound guided management to prevent neonatal complications to ensure optimal antenatal care. RESEARCH DESIGN AND METHODS The study was a randomized controlled trial, conducted in the Department of Obstetrics & Gynaecology at Christian Medical College and Hospital(CMCH), a tertiary hospital in south India between May 2019 to September 2021. There are approximately 12,000 deliveries conducted every year in this department. The study protocol was reviewed and approved by Ethics committee and Institutional review board (IRB Min. No. 11581), CMCH, Vellore and the study was registered with the Clinical Trials Registry of India (CTRI/2019/01/017130). Universal screening with the cut off values suggested by IADPSG, using the 75 gm oral glucose tolerance test with atleast one abnormal value was used to diagnose GDM(2). When the fasting blood glucose level ≥ 92 mg/dl (5.1 mmol)/or 1 h ≥ 180 mg/dl (10.0 mmol/L )/ or 2 h ≥ 153 mg/dl (8.5 mmol/L) were abnormal, the woman was started on medical nutritional therapy(MNT). Women not well controlled on MNT with moderate hyperglycaemia were started on oral hypoglycemic agents. Thus women well controlled on MNT and or oral hypoglycemic agents with optimal control with fasting blood glucose level ≤ 95mg/dl (5.3 mmol/L) or 2 hour post prandial level of ≤ 140mg/dl (7.8 mmol/L )between 28–32 weeks were recruited for the study. Patient information sheet was given to all participants and written consent obtained. Women with pregestational diabetes, hypertension, twin gestation or women with values above the target values or gestational age before 28 weeks and those after 32 weeks were excluded from the study. In this setting, women with GDM with good glycaemic control with fasting value of ≤ 95 mg/dL (5.3mmol/lt) or postprandial value ≤ 140 mg/dl (7.8 mmol/lt) were assessed at antenatal visits only once in three weeks for glycaemic control after 28 weeks for pragmatic reasons and this regime was the standard regime. Increased number of visits was only if the glycaemic control was not adequate or if the symphysio fundal height was increased on clinical examination. The second regime followed in the study was an ultrasound guided regime (USGR) where a baseline fetal ultrasound at randomization decided the frequency of visits. Women with abdominal circumference(AC) of above 70th centile according to the fetal growth standards [ 14 ]were advised to have antenatal visits every two weeks. Women with lower abdominal circumference on ultrasound were seen only once in 3 weeks. Randomisation to either the standard regime or USGR was by computer generated block randomization of sizes 2,4,6 using SAS software. Allocation concealment, was done by a statistician by placing each allocation in separate identical envelops that were numbered consecutively with serial numbers. These envelops were placed in a central office. Women were counselled to continue medical nutritional therapy with or without oral hypoglycemic agents to maintain optimal glycemic control. If the values were above the target values, fasting value > 95mg/dl (5.3 mmol/L) or 2 hour post prandial level of > 140mg/dl (7.8 mmol/L), they were started on oral hypoglycemic drugs and reviewed in 3 weeks and doses increased in a stepwise fashion, if fasting and post prandial values were still above the target values. Patients under USGR had a growth scan done to obtain an AC measurement. Patients who had AC more than or equal to the 70th centile for the gestational age[ 14 ] were advised visits once in two weeks with fasting and 2-hour post prandial glucose till delivery. They were started on OHA if fasting/2 hour postprandial were above the target values mentioned earlier, despite optimal MNT. Women whose AC was < 70th percentile were followed up once in 3 weeks as in the standard regime. After delivery, all neonates were followed up in the ward. The details of the pregnancy, delivery and neonatal outcomes were recorded by trained research officers. The primary outcome of the study was a composite of neonatal outcomes that included: i) Macrosomia – defined as birthweight > 3.7 kg based on the 90th percentile by local birthweight data [ 15 ]ii) Hypoglycaemia- two capillary glucose levels < 45mg/dl(2.5 mmol/L) atleast 30 minutes apart iii)Hyperbilirubinemia- elevated serum bilirubin levels requiring phototherapy iv) Respiratory distress – four or more hours of respiratory support or oxygen with associated diagnosis v) Stillbirth vi) Birth trauma – if there was shoulder dystocia,clavicle fracture or brachial plexus injury. Secondary outcomes included maternal glycaemic control, pregnancy induced hypertension, increased severity of diabetes( women who needed insulin in addition to OHA), induction of labour before 39 weeks, caesarean delivery, total number of antenatal visits and complications of vaginal delivery such as third and fourth degree perineal tears, Post Partum Hemorrhage( PPH),Preterm delivery(< 37 weeks) and nursery admissions. A sample size of 588 was required (294 subjects in each arm) to detect a difference of 10% in complication rate between the two groups, to provide a power of 80% and a 5% level of significance.The data was expressed as frequencies and percentages for qualitative variables and mean and standard deviations for quantitative variables. Differences in the primary and secondary outcome variables were compared by the χ2 test for categorical variables and a two-sample t-test for continuous variables. Absolute differences in the outcomes between the two randomised groups were estimated with 95% CI. The results were considered significant if p < 0.05. Statistical analysis was carried out by using SPSS windows version 11, SPSS Chicago RESULTS A total of 588 women were randomized, 294 to each management arm (Ref Fig.1). 77 women did not complete the study and were excluded for analysis- 31 in standard arm ( 20 women delivered outside and were lost to follow up and 11 dropped out of the study before completion). 52 in USGR arm( 31 women were lost to follow up and delivered elsewhere, 21 dropped out of the study). Data for neonatal outcomes were available in all the patients who completed the study. Baseline demographic characteristics details for both groups are entered in Table 1. Maternal age, Socio Economic Class, parity, maternal BMI, mode of diagnosis by fasting plasma glucose or OGTT were not significantly different between the two study groups (Table 1). The gestational age for recruitment and delivery were also similar between the two groups. The mean proportion of women who need oral hypoglycemics in addition to MNT were similar in both the groups. Thus both the study groups had similar baseline characteristics. The primary outcomes were the composite of adverse neontal outcomes which included hypoglycemia, hyperbilirubinemia, respiratory distress, birth trauma, still birth and these did not differ between the two groups.There were no stillbirths in both the study groups. Secondary outcomes which included maternal outcomes like pregnancy induced hypertension, caesarean delivery, increased severity of diabetes( treatment plan included addition of insulin along with oral hypoglycemics), 3 rd and 4 th degree perineal tear, for women who underwent vaginal or instrumental delivery, Post Partum hemorrhage(PPH), Preterm delivery( <37 weeks) and nursery admissions were similar between the two groups. The mean of antenatal visits between the two groups was also similar(2.40 vs 2.57) The number of neonates that required nursery admissions was also similar in both the groups. Nursery admissions included neonates with prematurity, low birth weight, feed intolerance, suspected sepsis. Analysis based on the number of antenatal visits was done between standard group and ultrasound subgroups{ standard group + ultrasound subgroup with AC <70 th centile(n=212) vs ultrasound subgroup with AC≥70 th centile(n=30) }. This showed a few significant results(Table 3 & 4). The number of antenatal visits was significantly more (2.36 vs 4.33, P<0.001) in the ultrasound subgroup of women with fetal AC≥70 th centile as they were called every 2 weeks for strict glycemic control. There were no differences in neonatal hypoglycemia, hyperbilirubinemia, respiratory distress and nursery admissions, but the significant difference in the birthweight was seen. The proportion of women who had macrosomic babies(3.59% vs 26.67%, P<0.001), increased severity of diabetes(2.97% vs 16.67%, P<0.001), 3 rd and 4 th degree perineal tear(2.95% vs 27.7%, P<0.001), PPH( 1.69% vs 16.67%, P<0.001)were more in the ultrasound subgroup with AC ≥70 th centile which was statistically significant as shown in table 4. DISCUSSION The salient finding of this randomized controlled study ,is that the ultrasound guided management of mild to moderate GDM did not reduce adverse neonatal outcomes. This study is important as no other trial has compared these two novel pragmatic regimes that are adapted to address the challenges faced by busy settings in the light of the increased prevalence of GDM with the revised diagnostic criteria(2). Though the USGR did not decrease adverse neonatal outcomes, a single abdominal circumference measurement at 28 to 32 weeks was effective in identifying fetuses that would have increased adverse outcomes. However this research did not asses if ultrasound measurement was superior to clinical examination for identification of macrosomic babies. We are unable to explain the reason for the significant increase in 3rd and 4th degree tears in the USGR group and this may be an incidental finding. In this study the identification of fetuses that have the potential to become macrosomic, did not prevent adverse outcomes in these women. This study cannot comment on the utility of increased number of visits and surveillance in this subset of women with GDM as the numbers were small. It is possible that, this increased surveillance decreased the severity of adverse outcomes in the neonate and mother even if there was no decrease in number of events. The strengths of the study was that there was good overall compliance (~ 10% lost to follow up in each study group). The neonatal and maternal outcomes were recorded by research officers who were masked to the intervention. The prevalence of neonatal adverse events in both the study groups were similar to other studies(5,11). This research is relevant only in the management of mild to moderate GDM which include 85% of cases of GDM. CONCLUSION This small well designed study did not show any advantage with USGR as compared to the pragmatic simple standard regime, in treatment of women with GDM. Declarations AUTHOR CONTRIBUTIONS: Anusha Reddy T, Shiny Nirupama B: Study design, literature review, manuscript submission. Arathy Raj: manuscript review, figures. Gowri Mahasampath performed the data analyses. Richa Sasmita T, Hilda Yenuberi, Swati Rathore, Jiji E Mathew verified the analyses. All authors have read, contributed to the work and approved the content. FUNDING STATEMENT: This research was funded by fluid Research grant provided by the institution under the grant number 22Z657. CONFLICT OF INTEREST STATEMENT The authors declare no conflicts of interest References HAPO Study Cooperative Research Group (2009) Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes 58(2):453–459 International Association of Diabetes and Pregnancy Study Groups Consensus Panel, Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA et al (2010) International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 33(3):676–682 Surapaneni T, Nikhat I, Nirmalan PK (2013) Diagnostic effectiveness of 75 g oral glucose tolerance test for gestational diabetes in India based on the International Association of the Diabetes and Pregnancy Study Groups guidelines. Obstet Med 6(3):125–128 Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS (2005) Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. N Engl J Med 352(24):2477–2486 Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B et al (2009) A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. N Engl J Med 361(14):1339–1348 Overview | Diabetes in pregnancy: management from preconception to the postnatal period | Guidance | NICE [Internet]. NICE; 2015 [cited 2023 Aug 16]. Available from: https://www.nice.org.uk/guidance/ng3 Gestational Diabetes [Internet]. [cited 2023 Aug 16]. Available from: https://www.acog.org/womens-health/faqs/gestational-diabetes Sinno SSH, Nassar AH (2019) Role of Ultrasonography in Pregnancies Complicated by Gestational Diabetes: A Review. Matern-Fetal Med 1(2):86 Balsells M, García-Patterson A, Gich I, Corcoy R (2014) Ultrasound-guided compared to conventional treatment in gestational diabetes leads to improved birthweight but more insulin treatment: systematic review and meta-analysis. Acta Obstet Gynecol Scand 93(2):144–151 Nelson LT, Wharton B, Grobman WA (2011) Prediction of large for gestational age birth weights in diabetic mothers based on early third-trimester sonography. J Ultrasound Med 30(12):1625–1628 Bonomo M, Cetin I, Pisoni MP, Faden D, Mion E, Taricco E et al (2004) Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial. Diabetes Metab 30(3):237–244 Schaefer-Graf UM, Kjos SL, Fauzan OH, Bühling KJ, Siebert G, Bührer C et al (2004) A randomized trial evaluating a predominantly fetal growth-based strategy to guide management of gestational diabetes in Caucasian women. Diabetes Care 27(2):297–302 Buchanan TA, Kjos SL, Montoro MN, Wu PYK, Madrilejo NG, Gonzalez M et al (1994) Use of Fetal Ultrasound to Select Metabolic Therapy for Pregnancies Complicated by Mild Gestational Diabetes. Diabetes Care 17(4):275–283 Ohuma EO, Villar J, Feng Y, Xiao L, Salomon L, Barros FC et al (2021) Fetal growth velocity standards from the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project. Am J Obstet Gynecol. ;224(2):208.e1-208.e18 Kumar VS, Jeyaseelan L, Sebastian T, Regi A, Mathew J, Jose R (2013) New birth weight reference standards customised to birth order and sex of babies from South India. BMC Pregnancy Childbirth 13(1):38 Tables Table 1 Baseline characteristics of the two study groups Variable Standard (n=263) USGR (n=242) Maternal Age (Years) a 28.21(4.18) 28.13(4.51) Socio Economic Class Upper b Middle b Lower b 31(11.79) 151(57.41) 81(30.80) 22(9.09) 158(65.29) 62(25.62) Parity Primi Gravida b Multi Gravida b 110(41.82) 153(58.17) 115(47.52) 133(54.95) Maternal BMI (Kg /m2) a 28.86(5.08) 28.65(4.19) Mode of diagnosis Fasting Plasma glucose b OGTT b 138(57.02) 125(51.65) 132(54.54) 116(47.93) Gestational age at recruitment (weeks) a 29.83(1.36) 30.22(1.29) Gestational age at delivery (weeks) a 38.49(1.62) 38.28(1.72) GDM on Diet b 261(99.23) 240(99.17) GDM on Diet + OHA'S b 56(23.14) 65(26.85) a Mean(SD) presented; b frequency (%) presented. USGR- Ultrasound Guided Regime Table-2 Neonatal and maternal outcomes of the two study groups Variable Standard (n=263) USGR (n=242) Difference (95% CI) P-value Birth weight( 3.7kg) b 12( 4.58) 13(5.39) -0.81 (-4.63, 3.00) 0.675 Neonatal Hypoglycemia b 15( 5.73) 12( 5.00) 0.73 (-3.21, 4.66) 0.719 Neonatal hyperbilirubinemia b 24( 9.16) 26( 10.88) -1.72 (-6.99, 3.55) 0.522 Respiratory distress b 9( 3.45) 16( 6.69) -3.25 (-7.11, 0.62) 0.096 Birth trauma b 1( 0.38) 1( 0.42) -0.03 (-1.14, 1.07) 0.950 Composite Neonatal outcome 52 (19.77) 59 (24.38) -4.61 (-11.85, 2.63) 0.212 a Mean(SD) presented; b frequency (%) presented. Table-3 Secondary outcomes of the two study groups Variable Standard (n=263) USGR (n=242) Difference (95% CI) P-value Average fasting glucose a 86.25(0.52) 86.49(0.51) -0.24 (-1.68, 1.20) 0.741 Average 2hr glucose a 110.25(1.14) 111.38(1.08) -1.12 (-4.22, 1.98) 0.477 No of Antenatal Visits a 2.40(0.07) 2.57(0.10) -0.17 (-0.41, 0.07) 0.173 Pregnancy induced HTN (PIH) b 17 (6.51) 19 (7.88) -1.37 (-5.90, 3.16) 0.552 Increased severity of diabetes b 10 (3.82) 9 (3.75) 0.07 (-3.27, 3.41) 0.969 Induction Of labour before 39 weeks b 50 (19.84) 59(25.00) -5.16 (-12.56, 2.24) 0.172 Caesarean delivery b 92 (35.11) 82(34.02) 1.09 (-7.23, 9.41) 0.797 3rd and 4th degree perineal tear b 5 (2.39) 12 (6.45) -4.06 (-8.15, 0.03) 0.047 Post partum hemorrhage b 6( 2.29) 7( 2.90) -0.62(-3.40, 2.17) 0.664 Preterm delivery( <37 weeks) b 27(10.26) 34(14.04) 5.16(-0.29,10.61) 0.162 Admission to nursery b 33(12.60) 38(15.83) -3.24 (-9.36, 2.88) 0.298 a Mean(SD) presented; b frequency (%) presented. Table-4 Neonatal and maternal outcomes based on abdominal circumference on ultrasound Variable Standard(263)+AC =70% (n=30) Difference (95% CI) P-value Birth weight b > 3.7kg 17(3.59) 8(26.67) -23.07(-38.98,-7.16) <0.001 Neonatal Hypoglycemia b 23(4.87) 4(13.33) -8.46(-20.78,3.86) 0.046 Neonatal hyperbilirubinemia b 46(9.77) 4(13.33) -3.56(-16.02,8.89) 0.527 Repiratory distress b 22(4.68) 3(10.00) -5.32(-16.22,5.58) 0.195 Birth trauma b 2(0.42) 0(0.00) 0.42(-0.16,1.01) NA Composite neonatal outcomes 100 (21.05) 11 (36.67) -15.61 (-33.24, 2.01) 0.045 Mean and sd Frequency and percentage, NA Due to low number p-value cannot be calculated Table-5 Secondary outcomes based on abdominal circumference on ultrasound Variable Standard(263)+AC =70% (n=30) Difference (95% CI) P-value Average fasting glucose a 86.24(8.21) 88.29(6.95) -2.05(-5.11,1.01) 0.189 Average 2hr glucose a 110.35(17.75) 117.88(12.51) -7.53(-14.10,-0.95) 0.025 No of Antenatal Visits a 2.36(1.26) 4.33(1.66) -1.97(-2.44,-1.49) <0.001 Pregnancy induced HTN (PIH) b 32(6.78) 4(13.33) -6.55(-18.92,5.82) 0.177 Increased severity of diabetes b 14(2.97) 5(16.67) -13.70(-27.12,-0.27) <0.001 Induction Of labour before 39 weeks b 103(22.34) 6(22.22) 0.12(-16.02,16.26) 0.988 Caesarean delivery b 163(34.46) 11(36.67) -2,21(-19.97,15.56) 0.805 3rd and 4th degree perineal tear b 11(2.95) 6(27.27) -24.32(-43.01,-5.63) <0.001 Post partum hemorrhage b 8( 1.69) 5( 16.67) -16.00(-28.36, -1.59) <0.001 Preterm delivery( <37 weeks) b 57(12.00) 4(13.33) -1.16(-10.29,8.61) 0.762 Admission to nursery b 65(13.77) 6(20.00) -6.22(-20.87,8.41) 0.342 Mean and sd Frequency and percentage, NA Due to low number p-value cannot be calculated Cite Share Download PDF Status: Posted Version 1 posted 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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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3818749","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":265360707,"identity":"cc69493d-09e4-47f4-9c8f-546f5ec49913","order_by":0,"name":"Anusha Reddy","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABA0lEQVRIiWNgGAWjYJACZjB5IAFIVNgACcbGA8RqYWxgOJMG0tJAghbGtsMQNj7l/LN7jD8X1NyT4zueY/7oBtt5u7Xth4G21NhE49IiceeMmfSMY8XGkmfeGDbn8NxO3nYmEajlWFpuAy49N3LMmHnYEhI33MgBapG4nWx2AKiFseEwTi3yN3KMP/P8S6iHaDE4l2x2/iF+LQY3cgykedsSEgzAWhIO2JndIGCL4Y20MmnevgTDmWeeFc7OOZCcYHYDaEsCHr/I3Uje/JnnW4I83/HkDZ9z/9nZm51Pf/jgQ40Nbu8jAIcBiEwEq0wgrBwE2B+ASHviFI+CUTAKRsFIAgCyfGqgo/utuwAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0009-0004-6720-892X","institution":"Christian Medical College and Hospital: Christian Medical College Vellore","correspondingAuthor":true,"prefix":"","firstName":"Anusha","middleName":"","lastName":"Reddy","suffix":""},{"id":265360708,"identity":"bf435349-7862-4ebf-b2f0-b9dc7acf83dd","order_by":1,"name":"Shiny nirupama","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Shiny","middleName":"","lastName":"nirupama","suffix":""},{"id":265360709,"identity":"8de8ca16-2ebc-441b-a379-ed08ea566b9c","order_by":2,"name":"Arathy Raj","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Arathy","middleName":"","lastName":"Raj","suffix":""},{"id":265360710,"identity":"0aac7353-d1f3-4d1a-983d-a0ed16752bca","order_by":3,"name":"Richa Sasmita Tirkey Sasmita Tirkey","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Richa","middleName":"Sasmita Tirkey Sasmita","lastName":"Tirkey","suffix":""},{"id":265360711,"identity":"6a1b3f55-9fe0-48e4-847a-f2617cd616db","order_by":4,"name":"Hilda Yenuberi","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Hilda","middleName":"","lastName":"Yenuberi","suffix":""},{"id":265360712,"identity":"852fd234-3b41-43a5-99df-2e456c82f012","order_by":5,"name":"Swati Rathore","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Swati","middleName":"","lastName":"Rathore","suffix":""},{"id":265360713,"identity":"e2c95e60-fc27-4aef-9e17-df5a86a6b8da","order_by":6,"name":"Jiji E Mathew","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Jiji","middleName":"E","lastName":"Mathew","suffix":""}],"badges":[],"createdAt":"2023-12-28 23:40:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3818749/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3818749/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":49332642,"identity":"61e436cf-c679-4e04-8f1d-8973aab50cbf","added_by":"auto","created_at":"2024-01-08 19:30:57","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":23575,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram for randomization\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUSGR- Ultrasound Guided Regime\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-3818749/v1/4c5ce792c5b21edcef7d57fd.png"},{"id":50232897,"identity":"c1a22fca-81df-4822-8081-b57794469cde","added_by":"auto","created_at":"2024-01-26 22:43:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":321016,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3818749/v1/994e9634-3d15-4169-98e4-72f1a475d046.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003eA Randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in low middle income countries\u003c/p\u003e","fulltext":[{"header":"Synopsis","content":"\u003cp\u003eThis study was to compare a pragmatic standard \u0026nbsp; management of \u0026nbsp;GDM \u0026nbsp;with ultrasound guided management to prevent neonatal complications to ensure optimal antenatal care. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study was registered with the Clinical Trials Registry of India(https://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=29575\u0026amp;EncHid=16049.63369\u0026amp;modid=1\u0026amp;compid=19%27,%2729575det%27)with the registration number (CTRI/2019/01/017130). \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e"},{"header":"INTRODUCTION","content":"\u003cp\u003eThe HAPO study [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] showed a continuum in increase or decrease of fetal weight that was directly proportionate to the maternal blood glucose levels. The revised diagnostic criteria that evolved from the research[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] doubled the prevalence of women with gestational diabetes (GDM)[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] and therefore increased the burden on health services. Moreover two large randomized controlled trials [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]confirmed the benefits of treating mild to moderate hyperglycaemia.\u003c/p\u003e \u003cp\u003eTreatment of GDM involves, increased number of antenatal visits to ensure good glycaemic control, which is the hallmark of optimal management of GDM. Ambulatory home blood glucose monitoring for newly diagnosed GDM that is often cured after delivery, is not popular with the woman and the care provider in under resourced countries, where patients compliance to treatment is a major concern. Most women with mild to moderate GDM can be treated with minor modifications in diet, but identifying women that need close surveillance is often a challenge. The guidelines advocated by major international bodies [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] on the frequency of visits and foetal surveillance is not based on good research. Ultrasound has been used to guide therapy but its use in the management of GDM has been used indiscriminately due to paucity of information[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eSome studies have shown that ultrasound has the potential to identify fetuses that can have neonatal complications[\u003cspan additionalcitationids=\"CR10 CR11 CR12\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] The use of ultrasound to guide the number of antenatal visits for adequate glycaemic control has not been researched adequately. There is also a need to contrive antenatal care strategies that can obtain optimal neonatal outcomes without burdening the health system in LMIC. Therefore, the aim of our study was to compare a pragmatic standard management of GDM with ultrasound guided management to prevent neonatal complications to ensure optimal antenatal care.\u003c/p\u003e"},{"header":"RESEARCH DESIGN AND METHODS","content":"\u003cp\u003eThe study was a randomized controlled trial, conducted in the Department of Obstetrics \u0026amp; Gynaecology at Christian Medical College and Hospital(CMCH), a tertiary hospital in south India between May 2019 to September 2021. There are approximately 12,000 deliveries conducted every year in this department. The study protocol was reviewed and approved by Ethics committee and Institutional review board (IRB Min. No. 11581), CMCH, Vellore and the study was registered with the Clinical Trials Registry of India (CTRI/2019/01/017130). Universal screening with the cut off values suggested by IADPSG, using the 75 gm oral glucose tolerance test with atleast one abnormal value was used to diagnose GDM(2). When the fasting blood glucose level\u0026thinsp;\u0026ge;\u0026thinsp;92 mg/dl (5.1 mmol)/or 1 h\u0026thinsp;\u0026ge;\u0026thinsp;180 mg/dl (10.0 mmol/L )/ or 2 h\u0026thinsp;\u0026ge;\u0026thinsp;153 mg/dl (8.5 mmol/L) were abnormal, the woman was started on medical nutritional therapy(MNT). Women not well controlled on MNT with moderate hyperglycaemia were started on oral hypoglycemic agents. Thus women well controlled on MNT and or oral hypoglycemic agents with optimal control with fasting blood glucose level\u0026thinsp;\u0026le;\u0026thinsp;95mg/dl (5.3 mmol/L) or 2 hour post prandial level of \u0026le;\u0026thinsp;140mg/dl (7.8 mmol/L )between 28\u0026ndash;32 weeks were recruited for the study. Patient information sheet was given to all participants and written consent obtained. Women with pregestational diabetes, hypertension, twin gestation or women with values above the target values or gestational age before 28 weeks and those after 32 weeks were excluded from the study.\u003c/p\u003e \u003cp\u003eIn this setting, women with GDM with good glycaemic control with fasting value of \u0026le;\u0026thinsp;95 mg/dL (5.3mmol/lt) or postprandial value\u0026thinsp;\u0026le;\u0026thinsp;140 mg/dl (7.8 mmol/lt) were assessed at antenatal visits only once in three weeks for glycaemic control after 28 weeks for pragmatic reasons and this regime was the standard regime. Increased number of visits was only if the glycaemic control was not adequate or if the symphysio fundal height was increased on clinical examination.\u003c/p\u003e \u003cp\u003eThe second regime followed in the study was an ultrasound guided regime (USGR) where a baseline fetal ultrasound at randomization decided the frequency of visits. Women with abdominal circumference(AC) of above 70th centile according to the fetal growth standards [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]were advised to have antenatal visits every two weeks. Women with lower abdominal circumference on ultrasound were seen only once in 3 weeks.\u003c/p\u003e \u003cp\u003eRandomisation to either the standard regime or USGR was by computer generated block randomization of sizes 2,4,6 using SAS software. Allocation concealment, was done by a statistician by placing each allocation in separate identical envelops that were numbered consecutively with serial numbers. These envelops were placed in a central office. Women were counselled to continue medical nutritional therapy with or without oral hypoglycemic agents to maintain optimal glycemic control. If the values were above the target values, fasting value\u0026thinsp;\u0026gt;\u0026thinsp;95mg/dl (5.3 mmol/L) or 2 hour post prandial level of \u0026gt;\u0026thinsp;140mg/dl (7.8 mmol/L), they were started on oral hypoglycemic drugs and reviewed in 3 weeks and doses increased in a stepwise fashion, if fasting and post prandial values were still above the target values. Patients under USGR had a growth scan done to obtain an AC measurement. Patients who had AC more than or equal to the 70th centile for the gestational age[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] were advised visits once in two weeks with fasting and 2-hour post prandial glucose till delivery. They were started on OHA if fasting/2 hour postprandial were above the target values mentioned earlier, despite optimal MNT. Women whose AC was \u0026lt;\u0026thinsp;70th percentile were followed up once in 3 weeks as in the standard regime.\u003c/p\u003e \u003cp\u003eAfter delivery, all neonates were followed up in the ward. The details of the pregnancy, delivery and neonatal outcomes were recorded by trained research officers. The primary outcome of the study was a composite of neonatal outcomes that included: i) Macrosomia \u0026ndash; defined as birthweight\u0026thinsp;\u0026gt;\u0026thinsp;3.7 kg based on the 90th percentile by local birthweight data [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]ii) Hypoglycaemia- two capillary glucose levels\u0026thinsp;\u0026lt;\u0026thinsp;45mg/dl(2.5 mmol/L) atleast 30 minutes apart iii)Hyperbilirubinemia- elevated serum bilirubin levels requiring phototherapy iv) Respiratory distress \u0026ndash; four or more hours of respiratory support or oxygen with associated diagnosis v) Stillbirth vi) Birth trauma \u0026ndash; if there was shoulder dystocia,clavicle fracture or brachial plexus injury.\u003c/p\u003e \u003cp\u003eSecondary outcomes included maternal glycaemic control, pregnancy induced hypertension, increased severity of diabetes( women who needed insulin in addition to OHA), induction of labour before 39 weeks, caesarean delivery, total number of antenatal visits and complications of vaginal delivery such as third and fourth degree perineal tears, Post Partum Hemorrhage( PPH),Preterm delivery(\u0026lt;\u0026thinsp;37 weeks) and nursery admissions.\u003c/p\u003e \u003cp\u003eA sample size of 588 was required (294 subjects in each arm) to detect a difference of 10% in complication rate between the two groups, to provide a power of 80% and a 5% level of significance.The data was expressed as frequencies and percentages for qualitative variables and mean and standard deviations for quantitative variables. Differences in the primary and secondary outcome variables were compared by the χ2 test for categorical variables and a two-sample t-test for continuous variables. Absolute differences in the outcomes between the two randomised groups were estimated with 95% CI. The results were considered significant if p\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Statistical analysis was carried out by using SPSS windows version 11, SPSS Chicago\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 588 women were randomized, 294 to each management arm (Ref Fig.1).\u0026nbsp;77 women did not complete the study and were excluded for analysis-\u0026nbsp;31 in standard arm ( 20 women delivered outside and were lost to follow up and 11 dropped out of the study before completion). 52 in USGR arm( 31 women were lost to follow up and delivered elsewhere, 21 dropped out of the study). Data for \u0026nbsp;neonatal\u0026nbsp;outcomes were available in all the patients who completed the study.\u003c/p\u003e\n\u003cp\u003eBaseline demographic characteristics details for both groups are entered in Table 1. Maternal age, Socio Economic Class, parity, maternal BMI, mode of diagnosis by fasting plasma glucose or OGTT were not significantly different between the two study groups (Table 1). The gestational age for recruitment and delivery were also similar between the two groups. The mean proportion of women who need oral hypoglycemics in addition to MNT were similar in both the groups. Thus both the study groups had similar baseline characteristics.\u003c/p\u003e\n\u003cp\u003eThe primary outcomes were the composite of adverse neontal outcomes which included hypoglycemia, hyperbilirubinemia, respiratory distress, birth trauma, still birth and these did not differ between the two groups.There were no stillbirths in both the study groups. Secondary outcomes which included maternal outcomes like pregnancy induced hypertension, caesarean delivery, increased severity of diabetes( treatment plan included addition of insulin along with oral hypoglycemics), 3\u003csup\u003erd\u003c/sup\u003e and 4\u003csup\u003eth\u003c/sup\u003e degree perineal tear, for women who underwent vaginal or instrumental delivery, Post Partum hemorrhage(PPH), Preterm delivery( \u0026lt;37 weeks) and nursery admissions were similar between the two groups. The mean of antenatal visits between the two groups was also similar(2.40 vs 2.57) The number of neonates that required nursery admissions was also similar in both the groups. Nursery admissions included neonates with prematurity, low birth weight, feed intolerance, suspected sepsis.\u003c/p\u003e\n\u003cp\u003eAnalysis based on the number of antenatal visits was done between standard group and ultrasound subgroups{ standard group + ultrasound subgroup with AC \u0026lt;70\u003csup\u003eth\u003c/sup\u003e centile(n=212) vs ultrasound subgroup with AC\u0026ge;70\u003csup\u003eth\u003c/sup\u003e centile(n=30) }. This showed a few significant results(Table 3 \u0026amp; 4). The number of antenatal visits was significantly more (2.36 vs 4.33, P\u0026lt;0.001) in the ultrasound subgroup of women with fetal \u0026nbsp; AC\u0026ge;70\u003csup\u003eth\u003c/sup\u003e centile as they were called every 2 weeks for strict \u0026nbsp;glycemic control. \u0026nbsp;There were no differences in neonatal hypoglycemia, hyperbilirubinemia, respiratory distress and nursery admissions, but the significant difference in the birthweight was seen. The proportion of women who had macrosomic babies(3.59% vs 26.67%, P\u0026lt;0.001), increased severity of diabetes(2.97% vs 16.67%, P\u0026lt;0.001), 3\u003csup\u003erd\u003c/sup\u003e and 4\u003csup\u003eth\u003c/sup\u003e degree perineal tear(2.95% vs 27.7%, P\u0026lt;0.001), PPH( 1.69% vs 16.67%, P\u0026lt;0.001)were more in the ultrasound subgroup with AC \u0026ge;70\u003csup\u003eth\u003c/sup\u003e centile which was statistically significant as shown in table 4.\u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe salient finding of this randomized controlled study ,is that the ultrasound guided management of mild to moderate GDM did not reduce adverse neonatal outcomes. This study is important as no other trial has compared these two novel pragmatic regimes that are adapted to address the challenges faced by busy settings in the light of the increased prevalence of GDM with the revised diagnostic criteria(2). Though the USGR did not decrease adverse neonatal outcomes, a single abdominal circumference measurement at 28 to 32 weeks was effective in identifying fetuses that would have increased adverse outcomes. However this research did not asses if ultrasound measurement was superior to clinical examination for identification of macrosomic babies. We are unable to explain the reason for the significant increase in 3rd and 4th degree tears in the USGR group and this may be an incidental finding.\u003c/p\u003e \u003cp\u003eIn this study the identification of fetuses that have the potential to become macrosomic, did not prevent adverse outcomes in these women. This study cannot comment on the utility of increased number of visits and surveillance in this subset of women with GDM as the numbers were small. It is possible that, this increased surveillance decreased the severity of adverse outcomes in the neonate and mother even if there was no decrease in number of events. The strengths of the study was that there was good overall compliance (~\u0026thinsp;10% lost to follow up in each study group). The neonatal and maternal outcomes were recorded by research officers who were masked to the intervention. The prevalence of neonatal adverse events in both the study groups were similar to other studies(5,11).\u003c/p\u003e \u003cp\u003eThis research is relevant only in the management of mild to moderate GDM which include 85% of cases of GDM.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThis small well designed study did not show any advantage with USGR as compared to the pragmatic simple standard regime, in treatment of women with GDM.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAUTHOR CONTRIBUTIONS:\u003c/p\u003e\n\u003cp\u003eAnusha Reddy T, Shiny Nirupama B: Study design, literature review, manuscript submission. \u0026nbsp;Arathy Raj: manuscript review, figures. Gowri Mahasampath performed the data analyses. Richa Sasmita T, Hilda Yenuberi, Swati Rathore, Jiji E Mathew verified the analyses. All authors have read, contributed to the work and approved the content.\u003c/p\u003e\n\u003cp\u003eFUNDING STATEMENT:\u003c/p\u003e\n\u003cp\u003eThis research was funded by fluid Research grant provided by the institution under the grant number 22Z657.\u003c/p\u003e\n\u003cp\u003eCONFLICT OF INTEREST STATEMENT\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHAPO Study Cooperative Research Group (2009) Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes 58(2):453\u0026ndash;459\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eInternational Association of Diabetes and Pregnancy Study Groups Consensus Panel, Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA et al (2010) International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 33(3):676\u0026ndash;682\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSurapaneni T, Nikhat I, Nirmalan PK (2013) Diagnostic effectiveness of 75 g oral glucose tolerance test for gestational diabetes in India based on the International Association of the Diabetes and Pregnancy Study Groups guidelines. Obstet Med 6(3):125\u0026ndash;128\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCrowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS (2005) Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes. N Engl J Med 352(24):2477\u0026ndash;2486\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLandon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B et al (2009) A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes. N Engl J Med 361(14):1339\u0026ndash;1348\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOverview | Diabetes in pregnancy: management from preconception to the postnatal period | Guidance | NICE [Internet]. NICE; 2015 [cited 2023 Aug 16]. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nice.org.uk/guidance/ng3\u003c/span\u003e\u003cspan address=\"https://www.nice.org.uk/guidance/ng3\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGestational Diabetes [Internet]. [cited 2023 Aug 16]. 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Acta Obstet Gynecol Scand 93(2):144\u0026ndash;151\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNelson LT, Wharton B, Grobman WA (2011) Prediction of large for gestational age birth weights in diabetic mothers based on early third-trimester sonography. J Ultrasound Med 30(12):1625\u0026ndash;1628\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBonomo M, Cetin I, Pisoni MP, Faden D, Mion E, Taricco E et al (2004) Flexible treatment of gestational diabetes modulated on ultrasound evaluation of intrauterine growth: a controlled randomized clinical trial. Diabetes Metab 30(3):237\u0026ndash;244\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchaefer-Graf UM, Kjos SL, Fauzan OH, B\u0026uuml;hling KJ, Siebert G, B\u0026uuml;hrer C et al (2004) A randomized trial evaluating a predominantly fetal growth-based strategy to guide management of gestational diabetes in Caucasian women. Diabetes Care 27(2):297\u0026ndash;302\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBuchanan TA, Kjos SL, Montoro MN, Wu PYK, Madrilejo NG, Gonzalez M et al (1994) Use of Fetal Ultrasound to Select Metabolic Therapy for Pregnancies Complicated by Mild Gestational Diabetes. Diabetes Care 17(4):275\u0026ndash;283\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOhuma EO, Villar J, Feng Y, Xiao L, Salomon L, Barros FC et al (2021) Fetal growth velocity standards from the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project. Am J Obstet Gynecol. ;224(2):208.e1-208.e18\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKumar VS, Jeyaseelan L, Sebastian T, Regi A, Mathew J, Jose R (2013) New birth weight reference standards customised to birth order and sex of babies from South India. BMC Pregnancy Childbirth 13(1):38\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1 Baseline characteristics of the two study groups\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"475\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVariable\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eStandard\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=263)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eUSGR\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=242)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp;Maternal Age (Years) \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e28.21(4.18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e28.13(4.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp;Socio Economic Class\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; Upper \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp;Middle \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp;Lower \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 31(11.79)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 151(57.41)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 81(30.80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 22(9.09)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; 158(65.29)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;62(25.62)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp;Parity\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Primi Gravida \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Multi Gravida \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e110(41.82)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 153(58.17)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e115(47.52)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 133(54.95)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; Maternal BMI (Kg /m2) \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e28.86(5.08)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp; 28.65(4.19)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eMode of diagnosis \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Fasting Plasma glucose\u003csup\u003eb \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;OGTT \u003csup\u003eb \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e138(57.02)\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e125(51.65) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;132(54.54)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;116(47.93)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eGestational age at recruitment (weeks) \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e29.83(1.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e30.22(1.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; Gestational age at delivery \u0026nbsp; \u0026nbsp; (weeks) \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e38.49(1.62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e38.28(1.72)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eGDM on Diet \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e261(99.23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e240(99.17)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"49.26315789473684%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;GDM on Diet + \u0026nbsp;OHA\u0026apos;S \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"26.105263157894736%\" valign=\"top\"\u003e\n \u003cp\u003e56(23.14)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.63157894736842%\" valign=\"top\"\u003e\n \u003cp\u003e65(26.85)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Mean(SD) presented; \u003csup\u003eb\u003c/sup\u003e frequency (%) presented.\u003c/p\u003e\n\u003cp\u003eUSGR- Ultrasound Guided Regime \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable-2 Neonatal and maternal outcomes of the \u0026nbsp;two study groups\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVariable\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eStandard\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=263)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eUSGR\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=242)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eDifference (95% CI)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP-value\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eBirth weight( 3.7kg)\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e12( 4.58)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e13(5.39)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-0.81 (-4.63, 3.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.675\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNeonatal Hypoglycemia\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e15( 5.73)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e12( 5.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;0.73 (-3.21, 4.66)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.719\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNeonatal hyperbilirubinemia\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e24( 9.16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e26( 10.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-1.72 (-6.99, 3.55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.522\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eRespiratory distress \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e9( 3.45)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e16( 6.69)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-3.25 (-7.11, 0.62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.096\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eBirth trauma \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e1( 0.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e1( 0.42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-0.03 (-1.14, 1.07)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.950\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eComposite Neonatal outcome\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e52 (19.77)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e59 (24.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-4.61 (-11.85, 2.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.212\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Mean(SD) presented; \u003csup\u003eb\u003c/sup\u003e frequency (%) presented.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable-3 \u0026nbsp;Secondary outcomes of the \u0026nbsp;two study groups\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"614\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVariable\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eStandard\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=263)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eUSGR\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=242)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eDifference (95% CI)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP-value\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAverage fasting glucose \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e86.25(0.52)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e86.49(0.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-0.24 (-1.68, 1.20)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.741\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAverage 2hr glucose \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e110.25(1.14)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e111.38(1.08)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-1.12 (-4.22, 1.98)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.477\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNo of Antenatal Visits \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e2.40(0.07)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e2.57(0.10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-0.17 (-0.41, 0.07)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.173\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePregnancy induced HTN (PIH) \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e17 (6.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e19 (7.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-1.37 (-5.90, 3.16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.552\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eIncreased severity of diabetes\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e10 (3.82)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e9 (3.75)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e0.07 (-3.27, 3.41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.969\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eInduction Of labour before 39 weeks \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e50 (19.84)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e59(25.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-5.16 (-12.56, 2.24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.172\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCaesarean delivery\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e92 (35.11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e82(34.02)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e1.09 (-7.23, 9.41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.797\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e3rd and 4th degree perineal tear\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e5 (2.39)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e12 (6.45)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-4.06 (-8.15, 0.03)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.047\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePost partum hemorrhage\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e6( 2.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e7( 2.90)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-0.62(-3.40, 2.17)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.664\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePreterm delivery( \u0026lt;37 weeks) \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e27(10.26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e34(14.04)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e5.16(-0.29,10.61)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.162\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.1219512195122%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAdmission to nursery \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.422764227642276%\" valign=\"top\"\u003e\n \u003cp\u003e33(12.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.097560975609756%\" valign=\"top\"\u003e\n \u003cp\u003e38(15.83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"23.089430894308943%\" valign=\"top\"\u003e\n \u003cp\u003e-3.24 (-9.36, 2.88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.268292682926829%\" valign=\"top\"\u003e\n \u003cp\u003e0.298\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003csup\u003ea\u003c/sup\u003e Mean(SD) presented; \u003csup\u003eb\u003c/sup\u003e frequency (%) presented.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable-4 Neonatal and maternal outcomes based on abdominal circumference on ultrasound\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"672\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVariable\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eStandard(263)+AC\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026lt;70%(212)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n= 475)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAC\u0026gt;=70%\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=30)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eDifference (95% CI)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP-value\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eBirth weight\u003csup\u003eb\u0026nbsp;\u003c/sup\u003e\u0026gt; 3.7kg\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e17(3.59)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e8(26.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-23.07(-38.98,-7.16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNeonatal Hypoglycemia \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e23(4.87)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e4(13.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-8.46(-20.78,3.86)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.046\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNeonatal hyperbilirubinemia\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e46(9.77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e4(13.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-3.56(-16.02,8.89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.527\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eRepiratory distress \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e22(4.68)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e3(10.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-5.32(-16.22,5.58)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.195\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eBirth trauma\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e2(0.42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e0(0.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e0.42(-0.16,1.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eComposite neonatal outcomes\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e100 (21.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e11 (36.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;-15.61 (-33.24, 2.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.045\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003col start=\"1\" style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eMean and sd\u003c/li\u003e\n \u003cli\u003eFrequency and percentage, NA Due to low number p-value cannot be calculated\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable-5 Secondary outcomes based on abdominal circumference on ultrasound\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"672\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eVariable\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eStandard(263)+AC\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026lt;70%(212)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n= 475)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAC\u0026gt;=70%\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e(n=30)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eDifference (95% CI)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eP-value\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAverage fasting glucose \u003csup\u003ea\u0026nbsp;\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e86.24(8.21)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e88.29(6.95)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-2.05(-5.11,1.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.189\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAverage 2hr glucose \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e110.35(17.75)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e117.88(12.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-7.53(-14.10,-0.95)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.025\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eNo of Antenatal Visits \u003csup\u003ea\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e2.36(1.26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e4.33(1.66)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-1.97(-2.44,-1.49)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePregnancy induced HTN (PIH) \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e32(6.78)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e4(13.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-6.55(-18.92,5.82)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.177\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eIncreased severity of diabetes\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e14(2.97)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e5(16.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-13.70(-27.12,-0.27)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eInduction Of labour before 39 weeks\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e103(22.34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e6(22.22)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e0.12(-16.02,16.26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.988\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eCaesarean delivery \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e163(34.46)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e11(36.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-2,21(-19.97,15.56)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.805\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003e3rd and 4th degree perineal tear\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e11(2.95)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e6(27.27)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-24.32(-43.01,-5.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePost partum hemorrhage\u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e8( 1.69)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e5( 16.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-16.00(-28.36, -1.59)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003ePreterm delivery( \u0026lt;37 weeks) \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e57(12.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e4(13.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-1.16(-10.29,8.61)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.762\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"32.3397913561848%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cem\u003eAdmission to nursery \u003csup\u003eb\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"18.330849478390462%\" valign=\"top\"\u003e\n \u003cp\u003e65(13.77)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"16.84053651266766%\" valign=\"top\"\u003e\n \u003cp\u003e6(20.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"22.652757078986586%\" valign=\"top\"\u003e\n \u003cp\u003e-6.22(-20.87,8.41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"9.836065573770492%\" valign=\"top\"\u003e\n \u003cp\u003e0.342\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003col start=\"1\" style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eMean and sd\u003c/li\u003e\n \u003cli\u003eFrequency and percentage, NA Due to low number p-value cannot be calculated\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"gestational diabetes, ultrasound, standard, macrosomia, glycemic control","lastPublishedDoi":"10.21203/rs.3.rs-3818749/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3818749/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThe aim of the study is to see if single ultrasound scan in the early third trimester could identify women who need frequent visits for strict glycemic control and the impact on neonatal and maternal outcomes in clinical practice.We decided not to look at serial ultrasounds to detect accelerated growth as it would be expensive, time consuming and difficult to replicate in normal practice.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe study was a randomized controlled trial, conducted at Christian Medical College and Hospital(CMCH), a tertiary hospital in south India. The study population was recruited from women who visited antenatal outpatient clinic in the department of Obstetrics and Gynaecology, CMCH, Vellore between May 2019 to September 2021\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003e588 women were included in the study. Outcomes between conventional and ultrasound subgroups ( Standard\u0026thinsp;+\u0026thinsp;ultrasound subgroup with AC\u0026thinsp;\u0026le;\u0026thinsp;70 th centile vs ultrasound subgroup AC\u0026thinsp;\u0026ge;\u0026thinsp;70 th centile)showed significant difference in outcomes.Ultrasound subgroup with AC\u0026thinsp;\u0026ge;\u0026thinsp;70 th centile had macrosomia(3.59% vs26.67%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001),increased severity of diabetes(2.97% vs 16.67%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), 3 rd and 4 th degree perineal tear(2.95% vs 27.27%, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001) .\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThus in conclusion this small well designed study did not show any advantage with USGR as compared to the pragmatic simple standard regime, in treatment of women with GDM.\u003c/p\u003e","manuscriptTitle":"A Randomized controlled trial comparing two antenatal care regimes in the management of mild to moderate gestational diabetes in low middle income countries","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-08 19:30:53","doi":"10.21203/rs.3.rs-3818749/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"6f0960d8-f265-4019-b273-282b63a00b2e","owner":[],"postedDate":"January 8th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-01-26T22:35:44+00:00","versionOfRecord":[],"versionCreatedAt":"2024-01-08 19:30:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3818749","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3818749","identity":"rs-3818749","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}