A clinical study on the effect of programmed labor on feto-maternal outcome

Background: Stress of labor pain disturbs the maternal autonomic functions and liberates catecholamines which predisposes to dysfunctional labor and compromise fetal oxygenation. Freedom from pain improves the environment for both mother and fetus and therapy improves obstetric outcome. The objective of the study was to evaluate the efficacy of programmed labor protocol in providing shorter, safer and relatively pain free deliveries.Methods: 100 primigravidae with term pregnancy (37-41 wks) meeting inclusion criteria were enrolled in the study. Alternate women were allocated to two groups-study group (50) and control group (50). Programmed labor protocol was initiated in study group and control group were managed expectantly as per hospital protocol. Feto maternal outcome variables were noted.Results: In study group there was a marked reduction of the active phase of labor. The mean duration of cervical dilatation was nearly double (2.3+/-0.3 cm/hr) than the control group (1.2+/-0.4cm/hr) resulting in shortening of the duration of both first as well as second stage in the study group. In the study there was 66% of women has good pain relief 20% of women has moderate pain relief. No neonatal mortality or life threatening complications were seen in both the groups.Conclusions: Programmed labor protocol can be used by all clinicians with high benefit and safety margin

Study of efficacy of mifepristone as inducing agent for mid trimester medical termination of pregnancy in women with previous cesarean section

Background: Second trimester pregnancy induction in the scenario of a prior caesarean birth has become an increasingly common due to improved prenatal screening methods. The objective of this study was to evaluate efficacy of Mifepristone as inducing agent for mid trimester medical termination of pregnancy in women with previous cesarean section.Methods: Mifepristone 200 mg orally was given to 37 women willing for abortion between 13 to 20 weeks of gestation with previous LSCS for various indications during study period. After 36 hour misoprostol/oxytocin was given. Outcomes like rate of complete abortion, rupture, induction abortion interval and side effects were noted.Results: Mean induction abortion interval (IAI) was 8.2+/- 3.8 hours.80% of cases between 13 to 16 weeks aborted within first 10 hours. None of the cases had incomplete abortion, rupture or significant side effects.Conclusions: Combination regimen has abortion rate as higher as 99-100% and median induction to abortion interval is as low as 6 hours. Second trimester abortion in prior cesarean section women should be carried out with caution

Comparative study of efficacy and safety of intravenous ferric carboxy maltose versus iron sucrose in treatment of postpartum iron deficiency anemia

Background: Iron deficiency is the commonest treatable cause of postpartum anemia. Parenteral iron therapy results faster and higher replenishment of iron stores and correction of Hb levels with better compliance. The study was to compare the safety and efficacy of ferric carboxy maltose (FCM) with iron sucrose to treat iron deficiency anemia in the post-partum.Methods: 200 women of postpartum iron deficiency anemia were allocated into two groups. Iron sucrose group, subjects were given I.V. iron sucrose in multiple doses, 200 mg/day on  day 0,2,4,6,8  total of 1000 mg. FCM group , subjects were  given I.V. ferric carboxymaltose 1000 mg single dose.  Both groups Hb%, and serum ferritin were done on 0 and day 30 of last dose of parenteral iron. Side effects, compliance were noted.Results: There was statistically significant rise (P <0.001) of Hb in FCM group 4.68 g/dl compare to iron sucrose group 3.92 g/dl. Mean rise of serum ferritin was 71.07±27.23 and 95.39±45.84 in iron sucrose and ferric carboxy maltose group. No serious adverse events were reported in either the FCM group or Iron sucrose group.Conclusions: Properties like ultra-short duration of treatment, fewer adverse reactions and better compliance makes FCM the first-line drug in the management of postpartum iron deficiency anemia

Safety and efficacy of ferric carboxy maltose in pregnant women- a pilot study

Background: Iron deficiency is a common nutritional deficiency amongst women of childbearing age. It is associated with significant maternal, fetal and infant morbidity. Current options for treatment include oral iron, parenteral iron and red blood cell transfusions. Ferric carboxy maltose is a newer i.v. iron formulation which can be used at high doses with rapid administration. This study was undertaken to assess the safety and efficacy in pregnant women.Methods: Prospective observational study was conducted in VIMS Ballari. 50 pregnant women between 28-36 weeks of gestation having moderate anemia with confirmed iron deficiency were administered with 1000 mg of ferric carboxy maltose (FCM). These women were followed after 2 weeks, 4 weeks and till delivery. Safety and efficacy were assessed.Results: There was significant improvement in both hemoglobin and serum ferritin levels (p<0.01). None of them had significant reactions.Conclusions: Ferric carboxy maltose is well tolerated. Ability to transfuse in single high dose makes it a preferred drug for faster and higher replenishment of iron stores and correction of hemoglobin levels during pregnancy especially in third trimester

Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial

Cesarean section rates worldwide are rising, driven by medically unnecessary cesarean use. The new World Health Organization Labour Care Guide (LCG) aims to improve the quality of care for women during labor and childbirth. Using the LCG might reduce overuse of cesarean; however, its effects have not been evaluated in randomized trials. We conducted a stepped-wedge, cluster-randomized pilot trial in four hospitals in India to evaluate the implementation of an LCG strategy intervention, compared with routine care. We performed this trial to pilot the intervention and obtain preliminary effectiveness data, informing future research. Eligible clusters were four hospitals with >4,000 births annually and cesarean rates ≥30%. Eligible women were those giving birth at ≥20 weeks' gestation. One hospital transitioned to intervention every 2 months, according to a random sequence. The primary outcome was the cesarean rate among women in Robson Group 1 (that is, those who were nulliparous and gave birth to a singleton, term pregnancy in cephalic presentation and in spontaneous labor). A total of 26,331 participants gave birth. A 5.5% crude absolute reduction in the primary outcome was observed (45.2% versus 39.7%; relative risk 0.85, 95% confidence interval 0.54-1.33). Maternal process-of-care outcomes were not significantly different, though labor augmentation with oxytocin was 18.0% lower with the LCG strategy. No differences were observed for other health outcomes or women's birth experiences. These findings can guide future definitive effectiveness trials, particularly in settings where urgent reversal of rising cesarean section rates is needed. Clinical Trials Registry India number: CTRI/2021/01/03069

Study of efficacy of mifepristone as inducing agent for mid trimester medical termination of pregnancy in women with previous cesarean section

Background: Second trimester pregnancy induction in the scenario of a prior caesarean birth has become an increasingly common due to improved prenatal screening methods. The objective of this study was to evaluate efficacy of Mifepristone as inducing agent for mid trimester medical termination of pregnancy in women with previous cesarean section.Methods: Mifepristone 200 mg orally was given to 37 women willing for abortion between 13 to 20 weeks of gestation with previous LSCS for various indications during study period. After 36 hour misoprostol/oxytocin was given. Outcomes like rate of complete abortion, rupture, induction abortion interval and side effects were noted.Results: Mean induction abortion interval (IAI) was 8.2+/- 3.8 hours.80% of cases between 13 to 16 weeks aborted within first 10 hours. None of the cases had incomplete abortion, rupture or significant side effects.Conclusions: Combination regimen has abortion rate as higher as 99-100% and median induction to abortion interval is as low as 6 hours. Second trimester abortion in prior cesarean section women should be carried out with caution

Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: protocol and statistical analysis plan for a pragmatic, stepped-wedge, cluster-randomized pilot trial

Plain language summary The new WHO Labour Care Guide (LCG) is an innovative partograph that emphasises women-centred, evidence-based care during labour and childbirth. Together with clinicians working at four hospitals in India, we will develop and test a strategy to implement the LCG into routine care in labour wards of these hospitals. We will use a randomised trial design where this LCG strategy is introduced sequentially in each of the four hospitals, in a random order. We will collect data on all women giving birth and their newborns during this period and analyse whether the LCG strategy has any effects on the use of Caesarean section, women’s and newborn’s health outcomes, and women’s experiences during labour and childbirth. While the trial is being conducted, we will also collect qualitative and quantitative data from doctors, nurses and midwives working in these hospitals, to understand their perspectives and experiences of using the LCG in their day-to-day work. In addition, we will collect economic data to understand how much the LCG strategy costs, and how much money it might save if it is effective. Through this study, our international collaboration will generate critical evidence and innovative tools to support implementation of the LCG in other countries