Abstract
To assess the feasibility of administration of three doses of oral misoprostol (OM) 50 µg four hourly per day for 48 hours versus the insertion of a supra cervical Foley catheter for 48 hours, in women at 40 weeks + 5 days gestation, and compare the effectiveness of the two methods for induction of labour (IOL). An investigator blinded, randomized controlled trial was conducted at the academic obstetric unit, Teaching Hospital Mahamodara, Galle from 13.10.2016 to 30.04.2017. Consecutive women (n=144) with singleton uncomplicated pregnancies having Modified Bishop Score (MBS) <5 at 40weeks + 5days gestation were allocated by stratified (primigravidae/ multigravidae) block randomization to receive three doses of OM 50µg four hourly per day for 48 hours or a supra cervical Foley catheter for 48 hours. Compared to the Foley, OM resulted in higher rates of successful IOL (67% vs 47%, RR 1.4, 95% CI 1.1 - 2.0, p =0.029), more vaginal deliveries within 24 hours and 48 hours, shorter mean induction delivery intervals and greater mean increase in MBS in those not in labour after 48 hours. There was non-significant increased frequency of excessive uterine activity, cardiotocograph abnormalities and meconium stained liquor after OM but no differences in the rates of caesarean deliveries and maternal or neonatal morbidity or mortality between the two groups. The administration of three doses oral misoprostol (OM) 50 µg four hourly per day for 48 hours as well as the insertion of a supra cervical Foley catheter for 48 hours were feasible for women at 40 weeks + 5 days gestation, but OM was more effective than the Foley catheter for IOL.
Highlights
Oral misoprostol (OM) is becoming increasingly popular as a method of induction of labour (IOL) worldwide, mainly because of its ease of administration and convenience to the patient, in contrast to intravenous and per vaginal interventions [1]
At GA 41 weeks (48 hours after the interventions), successful IOL was significantly higher in the oral misoprostol (OM) group compared to the Foley catheter group, (67% vs 47%, relative risks (RR) 1.4, 95% confidence intervals (CI) 1.0 2.0, p=0.029)
The vaginal delivery within 24 hours (VD 24) and the vaginal delivery within 48hours (VD 48) were significantly greater in the OM group compared to the Foley catheter group (35% vs 8%, RR 4.2, 95% CI 1.8 - 9.5, p < 0.001 and 67% vs 44%, RR 1.5, 95% CI 1.1 - 2.0, p=0.012)
Summary
Oral misoprostol (OM) is becoming increasingly popular as a method of induction of labour (IOL) worldwide, mainly because of its ease of administration and convenience to the patient, in contrast to intravenous and per vaginal interventions [1]. In a previous study carried out in the academic obstetrics and gynaecology unit of the Teaching Hospital Mahamodera, Galle (THMG), it was shown that compared to a supracervical Foley catheter for 24 hours, three doses of OM 50μg four hourly was more effective for cervical ripening and even resulted in IOL in approximately 38% of women in the OM group compared to approximately 12% in the Foley catheter group [3]. The current practice in most obstetric units in Sri Lanka is to remove the supracervical Foley catheter after 24 hours, on account of concerns regarding the risks, especially ascending infection, if the Foley catheter is kept in situ longer. The current study was designed, to determine the feasibility and the effectiveness of these two methods
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