Is new onset hypertension in obese women more likely to be Gestational Hypertension? - A retrospective study.

Introduction: New onset hypertension is more common in antenatal women with increased Body Mass Index (BMI). This may be due to either gestational hypertension (GH) or pre-eclampsia (PE). GH unlike PE is not associated with poor perinatal outcomes and would not require interventions such as increased antenatal visits and induction of labour. Our study assessed the prevalence of GH and PE in women with increased BMI as compared to women with normal BMI. Setting and Design: Historical cohort of a large tertiary centre. Method and Materials: Data from the electronic birth registry of the labour room was used to identify women who had a BMI ≥ 35 kg/m2 at delivery. Women with a normal BMI matched for the mode of delivery was taken as control. 148 women with BMI ≥ 35 kg/m2 were compared with 140 women of normal BMI. Results: New onset hypertension was seen in 41.2% (61/148) and 8.6% (12/140) in the non-obese group RR 4.81 (2.7-8.54) P (<0.001). GH was seen in 24.3% in obese women and 2.9% in normal controls, RR (9.65 (3.54,26.34)), P (<0.001). PE was seen in 16.9% of obese women and 5.7% of women with normal BMI, RR (3.79 (1.78,8.08)) P (<0.001). Proportion of GH in women with new onset hypertension was seen in 59% of obese women with new onset hypertension and 33% of normal controls. Conclusion: This clinically relevant trend towards an increased proportion of GH highlights the importance of identifying pathophysiological mechanism for high BP in obesity when there is new onset hypertension.

Expectant versus immediate delivery in women with PPROM between 34 and 35+6 weeks: A Retrospective cohort.

CONTEXT: Studies comparing the efficacy of expectant management (EM) and immediate delivery (ID) in the management of women with preterm prelabor rupture of membranes (PPROM) between 34 and 35+6 weeks have not been done in a developing country. Although large multicentric studies show better outcomes with EM, the economic implications have not been studied. AIMS: This study compared women with PPROM between 34 and 35 +6 weeks, managed expectantly with women who were delivered immediately. SETTINGS AND DESIGN: Large tertiary center and retrospective cohort. METHODS AND MATERIALS: Data of 206 women with PPROM between 34 and 35+6 weeks managed with immediate delivery in the years 2014 and 2015 were compared with seventy-five women with PPROM managed expectantly in the years 2016 and 2017. STATISTICAL ANALYSIS USED: Data was summarized using mean standard deviation (SD) or median interquartile range for continuous variables and frequency and percentage for categorical variables. Continuous variables were compared using independent t-test and categorical variables were compared using Chi-square statistics. RESULTS: Neonatal sepsis was seen in 1/75 (1.3%) in the group managed expectantly and 12/206 (5.8%) in the ID group (P = 0.109). Respiratory distress was seen in 3/75 (4%) in the group managed expectantly and 22/206 (10.7%) with ID (P = 0.08). Chorioamnionitis was similar in both groups. Cesarean rate was 17.3% with expectant management and 28% with ID (P = 0.065). The mean hospital bill was ₹.33,494/- in the ED group and ₹.27,079/- in the ID group (P < 0.001). CONCLUSIONS: Expectant management was more expensive.

How safe is metformin when initiated in early pregnancy? A retrospective 5-year study of pregnant women with gestational diabetes mellitus from India.

BACKGROUND: The initiation of metformin in early pregnancy in Gestational Diabetes mellitus (GDM) remains controversial. The aim of our study was to assess the influence of Metformin on maternal and fetal outcomes when initiated within the first trimester of pregnancy in GDM. METHODS AND MATERIALS: A retrospective analysis of 540 women with diabetes complicating pregnancy (IADPSG criteria) over five years (January 2011 to May 2016) was done. The study population comprised of patients initiated on (a) metformin within the first trimester (Group A:n = 186), (b) metformin after the first trimester (Group B:n = 203) and (c) insulin at any time during their pregnancy (Group C:n = 151). The primary outcomes compared were prematurity, respiratory distress, birth trauma, 5-min APGAR score, neonatal hypoglycaemia and need for phototherapy, while secondary outcomes compared were neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance. RESULTS: Individual and composite primary or secondary outcomes in group A were similar to Groups B and C, though numerically higher premature births were seen in Group A. There was a 1.3% overall incidence of stillbirths/IUD, while 1.11% congenital anomalies were noted of which 2.15% were in group A and 1.32% were in Group C (p = .16). CONCLUSIONS: The initiation of metformin within the first trimester of pregnancy has no significant adverse maternal or fetal outcomes. However, vigilance for premature births is recommended in women exposed to metformin in early pregnancy.

A retrospective study of the prevalence and outcomes of syphilis in pregnancy in a 5-year period.

OBJECTIVE: To determine the prevalence of syphilis in pregnancy and to assess the effect of syphilis on maternal and perinatal outcomes. METHODS: In a retrospective study, data were reviewed for pregnant women who tested positive for syphilis during routine prenatal screening at a center in India between January 2011 and December 2015. Women with both a positive venereal disease research laboratory (VDRL) test and a positive Treponema pallidum hemagglutination assay (TPHA) were considered to have syphilis, and their maternal and fetal outcomes were assessed. RESULTS: Among 51 164 pregnant women who underwent VDRL testing during the study period, 343 women were VDRL-positive (seropositivity rate 0.7%) and 18 were both VDRL- and TPHA-positive and were considered to have syphilis (seropositivity rate <0.1%). Among these 18 women, there were two stillbirths, four preterm births, and five small-for-gestational-age neonates. CONCLUSION: Although the prevalence of syphilis was low in the study population, women who were affected had adverse perinatal outcomes. Routine screening of all pregnant women for syphilis as early as possible in pregnancy, with appropriate treatment and follow-up of affected women and newborns, should be done to reduce adverse pregnancy outcomes.

Randomized controlled trial of the effect of amniotomy on the duration of spontaneous labor.

OBJECTIVE: To investigate the effect of amniotomy on the duration of spontaneous labor. METHODS: In the present randomized controlled trial, women in spontaneous labor with singleton pregnancies presenting at a tertiary teaching hospital in South India between August 1, 2014, and October 31, 2015, were randomized in a 1:1 ratio to undergo amniotomy or conservative management. The primary outcome was the duration of labor. Per-protocol analyses were performed and the duration of labor was compared between the groups of patients. RESULTS: There were 144 patients randomized to each group. The median duration of labor was 235 minutes (interquartile range 117-355) in the amniotomy group and 364 minutes (interquartile range 201-580) in the conservative management group (P<0.001). CONCLUSION: Amniotomy was associated with a shorter duration of labor in comparison with conservative management in patients with singleton pregnancies experiencing spontaneous labor. Clinical Trials Registry-India: (CTRI) (CTRI/2014/12/005264).

A randomised double-blind placebo-controlled trial comparing stepwise oral misoprostol with vaginal misoprostol for induction of labour.

A comparison of induction of labour (IOL) using three doses of 25 µg vaginal misoprostol inserted at intervals of 4 h or more with a stepwise oral regime starting with 50 µg followed by two doses of 100 µg was studied in a double-blind placebo-controlled trial in a tertiary centre in South India. Primary outcome was vaginal delivery in 24 h. Significantly more women in the first group required oxytocin augmentation and a third dose of the drug than women in the second group. Uterine tachysystole and other maternal and neonatal complications were similar. Thus it is concluded that women induced with oral, as compared to vaginal misoprostol are more likely to labour without oxytocin.

A randomised controlled trial comparing 30 mL and 80 mL in Foley catheter for induction of labour after previous Caesarean section.

Inducing labour with a Foley balloon catheter rather than using oxytocin or prostaglandins is considered to be less risky if the uterus is scarred.1 It is not known if more fluid in the balloon is more effective without being more dangerous. Volumes of 80 mL and 30 mL were compared in 154 eligible women. Mode of delivery, duration of labour and delivery within 24 h were similar in both groups. However, the second group required oxytocin more frequently. Though more scar dehiscences occurred in the first group, the difference was not significant.

Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.

BACKGROUND: Two oral hypoglycaemic agents, metformin and glibenclamide, have been compared with insulin in separate large randomised controlled trials and have been found to be as effective as insulin in gestational diabetes. However, very few trials have compared metformin with glibenclamide. MATERIALS AND METHODS: Of 159 South Indian women with fasting glucose ≥5.5 mmol/l and ≤7.2 mmol/l and/or 2-h post-prandial value ≥6.7 mmol/l and ≤13.9 mmol/l after medical nutritional therapy consented to be randomised to receive either glibenclamide or metformin. 80 women received glibenclamide and 79 received metformin. Neonatal outcomes were assessed by neonatologists who were unaware that the mother was part of a study and were recorded by assessors blinded to the medication the mother was given. The primary outcome was a composite of neonatal outcomes namely macrosomia, hypoglycaemia, need for phototherapy, respiratory distress, stillbirth or neonatal death and birth trauma. Secondary outcomes were birthweight, maternal glycaemic control, pregnancy induced hypertension, preterm birth, need for induction of labour, mode of delivery and complications of delivery. RESULTS: Baseline characteristics were similar but for the higher fasting triglyceride levels in women on metformin. The primary outcome was seen in 35% of the glibenclamide group and 18.9% of the metformin group [95% CI 16.1 (2.5, 29.7); P = 0.02]. The difference in outcome related to a higher rate of neonatal hypoglycaemia in the glibenclamide group (12.5%) versus none in the metformin group [95% CI 12.5(5.3, 19.7); P = 0.001]. Secondary outcomes in both groups were similar. CONCLUSION: In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide.

Misoprostol versus Foley catheter insertion for induction of labor in pregnancies affected by fetal growth restriction.

OBJECTIVE: To compare 25µg of vaginal misoprostol with a Foley catheter for induction of labor (IOL) for fetal growth restriction. METHODS: A randomized controlled trial was conducted in a tertiary center in South India. Women with fetal growth restriction (n=100) were randomized to be induced with three doses of vaginal misoprostol (25µg) every 6hours or with an intracervical Foley catheter, inserted 12hours before rupture of membranes, and oxytocin if needed. The primary outcome was uterine tachysystole with fetal cardiotocography abnormalities. Secondary outcomes pertained to effectiveness, complications, and patient satisfaction. RESULTS: One woman in the misoprostol group and none in the Foley catheter group had uterine tachysystole. The duration of labor from IOL to delivery was similar in both groups (P=0.416). More women in the misoprostol group had a vaginal delivery within 12hours (26.1% versus 5.6%; P=0.005). Women induced with misoprostol were less likely to deliver by lower-segment cesarean delivery (15.2% versus 29.6%; P=0.168) and to require oxytocin augmentation (60.9% versus 85.2%; P=0.007). Complications were few in both group. CONCLUSION: Few women had uterine tachysystole with cardiotocography abnormalities. Vaginal misoprostol at 25µg was more effective than a Foley catheter for IOL in fetal growth restriction. Clinical Trials Registry India:CTRI/2014/02/004411.

Back to the future: examining type 2 diabetic vasculature using the gestational diabetic placenta.

Understanding the association between the intrauterine hyperglycemic milieu and the development of adult diabetic vasculopathy is of particular relevance in India, where diabetes and vascular disease are prevalent. The gestational diabetes mellitus placenta is a valuable tool to examine blood vessels that have been exposed to hyperglycemic cues. We report an interesting observation in a cohort of gestational diabetes mellitus foetal placental vasculature from South India. Transmission electron microscopy demonstrated pericyte detachment and pericyte ghost cells reminiscent of adult type 2 diabetic retinopathy, in gestational diabetes mellitus foetal placental blood vessels that were not observed in non-gestational diabetes mellitus placentas (p ≤0.001). Endothelial cell irregularity was observed in 76% gestational diabetes mellitus foetal blood vessels as compared with 10.4% non-gestational diabetes mellitus placental vasculature (p ≤0.001). Other abnormalities noted in gestational diabetes mellitus placenta included mitochondrial abnormalities, increased micro vessel density and thickening of basement membranes. These results suggest that adult type 2 diabetic vasculopathy has developmental origins in utero.

A nested case-control study to evaluate the association between fetal growth restriction and vitamin B12 deficiency.

OBJECTIVES: To study the association between maternal vitamin B12 levels and fetal growth restriction. METHODS: In this nested case-control study, a cohort of low-risk women attending the antenatal clinic had their blood samples taken and stored at 28-31 weeks gestation. They were followed until delivery. Fifty-eight women delivering babies less than 2500 g were taken as cases and an equal number of controls delivering babies more than 2500 g were taken from the same cohort. Their B12 levels were assayed and studied for statistical significance. RESULTS: The baseline characteristics of both groups were similar. The number of women with serum B12 levels less than 200 pg/mL were similar in both groups: 33% versus 29% (P = 0.84). Type of kitchen fuel used was taken as a surrogate marker for socioeconomic status. More women in the cases used non-LPG (liquid petroleum gas) kitchen fuels such as kerosene and wood than in controls, 35% versus 19% (P = 0.06). CONCLUSIONS: No association between maternal vitamin B12 levels and fetal growth restriction was found in this study. Low birth weight babies were more common in women of low socioeconomic status.