Abstract: Background: The use of prostaglandin preparations with or without oxytocin infusion is widely recognized and accepted as a standard method of induction of labor. It has been shown to reduce induction time and the risk of failed induction.
Aims and Objectives: To determine the efficacy and safety of intra-vaginal administration of misoprostol in cervical ripening and induction of labor in women with unfavorable cervix in term pregnancy for purpose of vaginal delivery and avoidance of unnecessary cesarean section.
Study design: This randomized open clinical trial was conducted in Department of the Obstetrics and Gynecology, Dhaka Medical College and Hospital from 1st January 2017 to 31stjuly 2017.
Materials and Methods: A total number of 100 patients with term pregnancy with single tone baby with unfavorable cervix (Bishop score less than 6), cephalic presentation were included in this study. Each woman was assigned to receive 50 microgram misoprostol vaginally. Assessment of the cervix was done before application of medication and was documented. Tablet of 200 microgram misoprostol were divided into 4 parts and each part containing 50 microgram misoprostol. Women who were selected for vaginal misoprostol, an initial dose of 50 microgram applied in the posterior vaginal fornix. If labor did not establish within 6 hours subsequent doses of 50 microgram were applied 6 hourly maximum up to 4 doses. Study medication was given 6 hourly until cervix was ripe or true labor pain was started.
Result: The mean maternal age was 22.4 (SD±2.9) years (range 18-32 years). Primigravida constituted 47% multigravida in 53 patients (53%).The mean gestational age was 40.5 (SD±1.3) weeks (range 38 t 42). Postdated pregnancy was the most frequent indication of induction (63.0%) followed by pregnancy induced hypertension (24%), intrauterine fetal death (diagnosed before induction) (8%) and gestational diabetes mellitus (5%).Bishop’s score was significantly raised after 6 hours vaginal misoprostol [4.63 (SD±1.17) VS 5.82 (SD±1.60); p<0.001]. The mean induction to vaginal delivery time was 14.6(SD±4.6) hours (range 6 to 23 hour), the induction to vaginal delivery time was<12 hours in 44.3% and 12-24 hours in 55.7% cases.The mode of delivery was vaginal in most of the cases 70% and cesarean section was 30%.Fetal distress was the most frequent indication of cesarean section (63.3%) followed by arrested labor (20%) and failed induction (16.7%). Maternal obstetric complications were postpartum hemorrhage (3%) without any ruptured uterus, tachy systole, hyper tonus uterus or hyper stimulation. Oxytocin augmentation was required in 23.0% cases. The maternal side effects were nausea or vomiting (5.0%), diarrhea (2%), fever (1.0%).Fetal outcome were normal baby (65%), APGAR <7 at 1 min (27.0%), resuscitation needed (27%), neonatal admission unit (13%), meconium passage (8%) and intrauterine fetal death (diagnosed before induction) (8%).
Conclusion: Vaginal misoprostol seems to be a promising drug for labor induction. Possible advantages of misoprostol may be the availability, ease of administration, well tolerability and most notably its dual action in cervical ripening and labor induction. However future studies focusing on dosing regimens and route of application are needed.
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