Randomized double-blind placebo controlled study of preinduction cervical priming with 25 µg of misoprostol in the outpatient setting to prevent formal induction of labour.

OBJECTIVE: To compare the efficacy of preinduction outpatient use of a single dose of 25 µg vaginal misoprostol between 381/2 and 40 weeks with that of placebo, to decrease the interval from intervention to delivery after stretch and sweep in low-risk gravid women with Bishop's score <4. METHOD: Sixty three women received 25 µg vaginal misoprostol and 63 women received placebo after stretch and sweep. RESULTS: The duration from intervention to delivery was 3.35 (1.12-9.46) days in the misoprostol group and 5.42 (2.39-10.11) days in the placebo group which was statistically significant (p = 0.029). Spontaneous labor was seen in 39 women (61.9 %) in the misoprostol group and 35 women (55.6 %) in the placebo group (p = 0.531). Eight women in the misoprostol group and 18 in the placebo group had Lower Segment Caesarean Section (LSCS) and this difference was also statistically significant (p = 0.027). There were no major maternal and neonatal complications in both groups. CONCLUSION: Preinduction use of 25 µg vaginal misoprostol after stretch and sweep in the outpatient setting decreased the intervention to delivery interval when compared to placebo.

C- reactive protein levels in women with prelabour rupture of membrane and women with normal labour.

Background: There is a very little information known about CRP in term pregnancies. It is a marker that is easily tested and is inexpensive. Although CRP has been used very effectively in diagnosing infection in the neonate, its clinical use and values have not been studied in term pregnancies. The level of CRP that is truly normal or clinically innocuous is not known. Objectives: This is a cross-sectional study to compare the CRP levels in antenatal women with PROM and women with normal labor and assess its utility to predict sepsis. Methods: This is a prospective study done over a period of one year and approved by the insititutional ethical committee (IRB. Min. No 11102[OBSERVE] dated 10.01.2018). Sample for CRP was collected from 112 antenatal women with prelabor rupture of membranes within 12 hours of admission (Group A) and from 112 antenatal women in spontaneous labor without rupture of membrane (Group B). CRP samples are processed by nephelometry method. Results: The median CRP value in Group A is 9.15 and Group B is 7.26, with no statistical difference. Chorioamnionitis, neonatal sepsis, and endometritis were similar in both the groups. Conclusion: CRP cannot be used as predictor for chorioamnionitis, endometritis, and neonatal sepsis. There was no significant difference in CRP levels between the two groups.

A randomized controlled trial to study the effect of IV hydration on the duration of labor in nulliparous women.

PURPOSE: To compare the effects of two different regimens of intravenous hydration and oral hydration on the duration of active labor. METHODS: Two hundred and ninety-three low risk term primigravida in active labor were randomized into three groups. The first group had 99 patients who received oral fluids only, the second group of 98 patients received intravenous Ringer lactate at the rate of 125 ml/h (IV 125 ml) and the third group had 96 patients who received intravenous Ringer lactate at a rate of 250 ml/h (IV 250 ml). Amniotomy and oxytocin administration were allowed according to the physician's discretion. RESULTS: The mean duration of labor in the oral fluid group was 391, 363 min in the 125 ml/h group and 343 min in the 250 ml/h group, P = 0.203. The incidence of prolonged labor more than 12 h in the oral fluid group was 7.1% in the oral fluid group, 4.1% in the 125 ml/h group and 3.1% in the 250 ml/h group, P = 0.402. The oxytocin requirement was 37% in the oral group, 32% in the 125 ml/h group and 33% in the 250 ml/h group, P = 0.68. There was a statistically significant reduction in the incidence of vomiting in patients receiving intravenous hydration, i.e. 24.2% in the oral group, 11.2% in the 125 ml/h group and 6.3% in the 250 ml/h group, P = 0.001. There was no difference in the mode of delivery, maternal or neonatal complications between the three groups. CONCLUSION: This study establishes a trend towards decreased incidence of prolonged labor and less vomiting in patients receiving intravenous hydration.

Induction of labor using Foley catheter with weight attached versus without weight attached: A randomized control trial.

OBJECTIVE: To assess the effectiveness in preventing cesarean section for failed induction by using Foley catheter for cervical ripening in comparison to Foley catheter with a weight attached to it. METHODS: A randomized control trial conducted between November 2018 and July 2020, which looked at induction of labor with 30-ml Foley catheter in one arm and the Foley placed with a 500 ml weight attached to it in the other arm. Primary outcome was the cesarean section rate. RESULTS: We randomized 399 women. Modes of delivery were similar in both groups. Numbers undergoing cesarean section for failed induction were higher in the group that underwent induction with Foley with weight but this was not statistically significant (45.7% vs 26.5%, P = 0.1). There was a shorter time to expulsion of the Foley with weight attached (mean ± standard deviation: 2.6 ± 3.3 h vs 10.9 ± 3.2 h, P < 0.001) but this did not translate into a difference in time to active labor or time to delivery. CONCLUSION: Placing a weight at the end of the Foley catheter for induction of labor does not affect the time to delivery or the rate of cesarean deliveries, although there is faster expulsion of the Foley. CLINICAL TRIAL REGISTRATION NO: CTRI/2018/10/016154.

Study protocol: 'a large cohort study of postnatal events in a not-for-profit referral centre in Vellore, South India'.

INTRODUCTION: In a large developing country, with diverse population characteristics and differential access to healthcare, it is important to identify factors that influence postnatal health. This knowledge will help frame recommendations to enhance universal postnatal care. METHODS AND ANALYSIS: A prospective cohort study will be conducted by recruiting all participants who deliver in a referral centre in South India during a 1-year period after written consent is obtained from them. In addition to clinical information pertaining to their delivery and demographics, details of physical health, mental health socioeconomic status and emotional support will also be collected. Every participant will be followed up physically and/or by telephonic consultation at 3, 9 and 18 months of their postnatal period to reassess their status and that of their babies. As there are several independent and dependent variables requiring multivariate analysis, a sample size of 10 000 is considered adequate. Any unplanned visits to a health facility will be enquired into and documented for analysis.During data analysis, the effect of Caesarean section, high-risk characteristics and gestational age of the baby at delivery on various outcome measures and postnatal status will be evaluated. Interpretation of the large volume of collected data will help frame recommendations to improve postnatal care ETHICS AND DISSEMINATION: The study is approved by the Institutional Review Boards (Research and Ethics Committees) of Christian Medical College, Vellore, Tamil Nadu, India (IRB 12178 date 24 June 2020).Women are provided with a detailed information sheet and written consent is obtained. They are reassured that their care will not be compromised if they do not consent to the study. Data will be available on the clinical trial portal to assist in the dissemination of results after the project is published. TRIAL REGISTRATION NUMBER: CTRI/2022/03/041343.

A prospective observational study of the follow-up of medical management of early pregnancy failure.

BACKGROUND: Medical termination for missed miscarriage with the use of 800 µg of vaginal misoprostol as a single agent is recommended as a cheap option before 14 weeks of gestation in developing countries. A few studies have looked at its efficacy. METHODS: A prospective, observational study was done on women having medical termination with up to three doses of 800 µg vaginal misoprostol at 12 hourly intervals. The number of women who needed check curettage was collected. Ultrasound findings if done were collated. Follow-up was done telephonically at the end of first week, fourth week and sixth week. RESULTS: The cohort comprised 145 women. The primary outcome was the need for curettage after expulsion of products following medical management and this was 49/145 (37.8%) of women. The induction expulsion interval was 36 hours. The mean endometrial thickness of the 113/145 women who had an ultrasound was 11 mm. The mean endometrial thickness in women who had check curettage was 18 mm. Persistent spotting was the only significant symptom at follow-up. Resumption of cycle at the end of the sixth week was seen in 105/132 (80.15%) of women who were followed up. CONCLUSION: Findings of our study showed the check curettage rate of 37.8%. However, the regime which we used, that is, 800 µg vaginal misoprostol at 12 hourly intervals had a long induction to expulsion interval of 36 hours. In all, 80% of women resumed normal cycles at the end of the sixth week. No significant complications were noted on follow-up.

Digital stretching of cervix in the active phase of labour to shorten its duration: a randomised control trial.

An assessment of the efficacy and satisfaction of women in active labour having digital cervical stretching compared to women who did not have this intervention. Ours was a randomised controlled trial at a tertiary centre in India. Low-risk women at term with vertex presentation in active labour with ruptured membranes and cervical dilation of 4-6 cm were included. Stretching to delivery interval was 247.5 ± 158.2 min in the intervention group and 265.5 ± 158.4 in the control group. The mode of delivery, incidence of cervical tear, and maternal, fetal and neonatal complications were similar in both groups. The Labour and Delivery Satisfaction Index (LADSI) was similar in both groups. While no significant discomfort was perceived with stretching, it does not appear to expedite labour.

A Case Control Study to Evaluate the Association between Primary Cesarean Section for Dystocia and Vitamin D Deficiency.

BACKGROUND: Milder forms of vitamin D deficiency could be responsible for poor muscular performance causing dysfunctional labor. The aim of our research was to study the association between vitamin D deficiency and primary cesarean section. MATERIALS AND METHODS: This was a case control study. Forty six women who delivered by primary cesarean section with dystocia as primary or secondary indication after 37 weeks of gestation were taken as cases and a similar number of women who delivered vaginally were taken as controls. Vitamin D deficiency was diagnosed when the serum 25(OH)D level was ≤20 ng/ml and this was compared between cases and controls. RESULTS: Median serum (OH) vitamin D levels was 23.3ng/ml among women who delivered by cesarean section and 26.2ng/ml among controls (p=0.196). Baseline characteristics were similar in both groups except for a strong association between Body Mass Index (BMI) and cesarean section, (29.7kg/m(2) in cases and 25.9kg/m(2) in controls p=0.001) seen in multivariate analysis. Vitamin D deficiency was seen in 34.8% of cases and 21.7% of controls (p=0.165). CONCLUSION: This small case control study did not show a significant association between vitamin D deficiency and primary cesarean section.

Acromegaly in pregnancy.

Pregnancy in a patient with acromegaly is a rare occurrence. Here in, we report a patient with acromegaly who presented to us in the 2(nd) trimester of pregnancy with visual loss in the right eye. Her vision improved after surgery. She went on to have an uneventful pregnancy and delivered a term baby, by caesarian section. One year following her delivery, she received stereotactic radiotherapy. Subsequent follow-up revealed that her tumor had regressed and her IGF-1 levels had normalized.

Retrospective cohort study comparing neonatal outcomes of women treated with glyburide or insulin in gestational diabetes: a 5-year experience in a South Indian teaching hospital.

OBJECTIVE: To assess the effectiveness of glyburide in preventing complications of gestational diabetes in neonates as compared to insulin. MATERIALS AND METHODS: Information from birth register, maternal and neonatal records were obtained. Five hundred and seventy-seven gestational diabetics with moderate hyperglycemia i.e., with highest fasting plasma glucose value of ≤130 mg/dl and/or highest post-prandial value of ≤250 mg/dl treated with insulin or glyburide were included from a cohort of 769 women needing additional therapy to initial diet therapy during a 5-year period. Thus neonatal outcomes of 303 women treated with insulin and 274 women treated with glyburide were compared. RESULTS: Baseline plasma glucose levels in the group treated with insulin were higher. The mean birth weight (SD) of the neonates in women treated with insulin was 3021.3 g (604.19) as compared to 3104.6 g (499.35, P = 0.07) in the group treated with glyburide. Neonatal outcomes such as hypoglycemia (4.9%, 3.6%, P = 0.44), hypocalcemia (1.3%, 0.7%, P = 0.48), polycythemia (1.7%, 0.7%, P = 0.31), macrosomia (11.6%, 8.7%, P = 0.26), congenital anomalies (2.1%, 2.3%, P = 0.87), birth trauma (1.4%, 1.2%, P = 0.79) were similar in both groups. Neonates of women treated with insulin were more likely to have hyperbilirubinemia (11.5%, 6.5%, P = 0.03). CONCLUSION: Neonatal outcomes of women treated with glyburide were comparable to those in women treated with insulin. More number of neonates of mothers treated with insulin had hyperbilirubinemia compared to neonates of mothers treated with glyburide (11.5%, 6.5% P = 0.03).