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A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF HOURLY TITRATED ORAL MISOPROSTOL AND FOUR HOURLY VAGINAL MISOPROSTOL FOR INDUCTION OF LABOUR AT TERM IN DELTA STATE: A TWO-CENTRE TRIPLE BLIND RANDOMISED CONTROLLED TRIAL

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Supervisor: Prof. P.N. Ebeigbe
Faculty: OBSTETRICS AND GYNAECOLOGY
Month: 11
Year: 2022

Abstract

ABSTRACT BACKGROUND: Induction of labour is a common obstetric procedure which is indicated when the benefits to the mother and/or foetus outweigh the benefits of continuing pregnancy. The most common pharmacological drugs used for labour induction are prostaglandins: dinoprostone and misoprostol. The “gold standard” according to available evidence is vaginal misoprostol. The main side effect of induction of labour is the increase in the caesarean section rate, compared to spontaneous vaginal deliveries. However several publications recently suggest that the administration of oral misoprostol solution for induction of labour in titrated manner is associated with a lower caesarean section rate and a better safety profile than vaginal misoprostol. These findings are however conflicting. OBJECTIVE: The objective of this study was to compare the efficacy and safety of hourly titrated doses of oral misoprostol and four hourly vaginal misoprostol for induction of labour at term in two institutions in Delta State. METHOD: This was a two-centre triple blind randomized controlled trial of hourly titrated oral misoprostol (TOM) and four hourly vaginal misoprostol (VM) in singleton pregnancies undergoing induction of labour at term at Delta State University Teaching Hospital, Oghara and Central Hospital, Warri, both in Delta State. Participants were randomised into two groups of 130 participants each. Group A was assigned misoprostol (Misoclear® 200 Marie Stopes International) in solution using a dose escalating design. They also received 25 mcg placebo misoprostol four hourly vaginally as described in group B. While group B received 25 mcg of misoprostol (same brand) vaginally every 4 hours until adequate uterine contraction was achieved or for a maximum duration of 24 hours (i.e. up to a maximum dose of 150 mcg). They also received water orally at the same dosage as described in the oral misoprostol group as placebo. The primary outcome was the rate of vaginal delivery within the first 24 hour after drug administration. The secondary outcomes included, the duration of active phase labour, induction delivery interval, caesarean section rate, total dose of oxytocin used, abnormal fetal heart rate patterns, abnormal uterine contractions and uterine rupture.

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