Prostaglandins With Estradiol Versus Prostaglandins Alone For Induction Of Labour In Unfavourable Cervix - One Year Randomized Control Trial At KLES Dr.Prabhakar Kore Charitable Hospital, Belagavi

Abstract

Introduction: Induction of labour (IOL) is defined as the process of artificially stimulating the uterus to start labor. Over the past few decades, induction incidence has increased due to increase in detection of high risks pregnancies. Prostaglandins have become one of the most effective pharmacological agents in inducing labour in an unfavorable cervix. However estrogen is a hormone involved in ripening of cervix, it increases the release of local hormones (prostaglandins) which help to ripen the cervix. So there is need to the study if addition of vaginal estradiol to prostaglandins would hasten the process of delivery interval without risks to both the mother and the fetus. Objective: Primary objective: To evaluate the efficacy of addition of vaginal estradiol with prostaglandins in induction of labor in an unfavourable cervix. Secondary objective: to assess maternal and fetal outcome. Methodology: Design: Randomized controlled study. Setting: KLE University’s Dr. Prabhakar Kore Hospital and Medical Research Center, Attached to Jawaharlal Nehru Medical College, Belagavi. Subjects: A prospective study of 120 pregnant women with unfavorable cervix fulfilling the eligibility criteria admitted in labour room within period between May 2015 to April 2016 were included in the study. Inclusion criteria: gestational age ≥ 36 weeks, singleton pregnancy, cephalic presentation, Bishop’s score ≤ 4, intact membrane. Exclusion criteria: previous LSCS or any scar on uterus, premature rupture of membrane, placenta previa. Intervention: An informed consent was taken and by simple randomisation using opaque sealed envelope, they were allotted either with prostaglandins (dinoprostone, PGE2 gel) intaracervically alone group Or, using prostaglandins (dinoprostone, PGE2 gel) intaracervically with 50mcg vaginal estradiol tablet in the first dose followed by prostaglandins alone in the subsequent next two doses, sixth hourly of maximum 3 doses till cervical ripening is achieved. Preinduction cervical evaluation was assessed using Bishop’s score before each induction and earlier whenever warranted. The following outcome measures were noted in both the groups: 1) Interval from initiation of induction to cervical ripening (a score ≤ 6 was taken as unfavourable and favourable when Bishop’s score ≥ 8 at the end of 18 hours after initial induction). 2) Interval from induction to establishment of active labour (in primigravida >3cm with >80% effacement and in multipara > 4cm). 3) Induction to delivery interval. 4) Number of doses of prostaglandins required in each group. Results: Main indications were postdated pregnancies (26.67%) and pre-eclampsia. In this study there is significantly longer mean interval time noted for induction to cervical ripening (12.88 ±4.91 vs. 8.92 ± 5.07; p <0.001), induction to active labour (16.97 ±4.93 vs. 11.02 ± 4.72; p <0.001) and induction to delivery time (21.97 ± 3.83 vs. 13.14 ± 4.98; p <0.001) in PGE2 group compared to combined PGE2 and estradiol group.It was noted that mean number of doses of PGE2 gel required was less in combined prostaglandins and estradiol group than prostaglandins group alone (p <0.001).Fetal outcome in both the groups were not statistically significant and hence were comparable. Conclusion: Estradiol along with prostaglandins acts as a potentiating inducing agent in cervical ripening process and induction of labour than prostaglandins alone. Also the number of doses of prostaglandins required was more prostaglandins alone group compared to combined prostaglandins and vaginal estradiol group. The fetal outcome showed similar beneficial outcome in both the groups.