Abstract
To compare three doses of oral misoprostol 50μg four hourly versus an intra-cervical Foley catheter for 24 hours, for pre-induction cervical ripening. Primary investigator blinded, randomised controlled trial conducted in 180 consecutive women with singleton uncomplicated pregnancies with Modified Bishop Score (MBS) 5 at 40 weeks + 6 days gestation, allocated by stratified (primigravida / multigravida) block randomization to receive three doses of oral misoprostol 50μg four hourly or an intra-cervical Foley catheter for 24 hours. MBS reassessed at 41 weeks gestation. If MBS 7, induction of labour (IOL) with amniotomy and intravenous oxytocin infusion. If MBS<7, cross over therapy with intracervical Foley catheter for misoprostol group, vaginal prostaglandin E2 for Foley group. At commencement, no significant differences in age, parity, body mass index and MBS between the two groups. Greater proportions established labour in both primigravidae (30% vs. 9%; RR=4.4, 95% CI 1.3-14.6; p=0.01) and multigravidae (44%.vs.16%; RR=4.3; 95% CI 1.6-11.8; p=0.003) before 41 weeks of gestation in misoprostol group compared to the Foley group. Among the multigravidae, the mean increase of MBS was greater in the misoprostol group (3.1; 95% CI 2.4-4) compared to the Foley group (2.4; 95% CI 1.9-2.7, p=0.04). One primigravida and two multigravidae developed hyper stimulation after misoprostol therapy. No significant differences in the other maternal and perinatal outcomes. Compared to an intra-cervical Foley catheter for 24 hours, three doses of oral misoprostol 50μg four hourly was more effective for cervical ripening and even resulted in IOL.
Highlights
Induction of labour (IOL) should be considered at 41 weeks gestation, especially in South Asia [1,2,3]
Greater proportions established labour in both primigravidae (30% vs. 9%; RR=4.4, 95% CI 1.3-14.6; p=0.01) and multigravidae (44%.vs.16%; RR=4.3; 95% CI 1.6-11.8; p=0.003) before 41 weeks of gestation in misoprostol group compared to the Foley group
The mean increase of Modified Bishop Score (MBS) was greater in the misoprostol group (3.1; 95% CI 2.4-4) compared to the Foley group (2.4; 95% CI 1.9-2.7, p=0.04)
Summary
Induction of labour (IOL) should be considered at 41 weeks gestation, especially in South Asia [1,2,3]. The insertion of an intra-cervical Foley catheter is a frequently used procedure for pre induction cervical ripening and IOL [6,7,8,9,10,11] This procedure may be associated with accidental rupture of membranes and infections, these risks do not appear to be significantly different from the risks of vaginal prostaglandins [8,10]. Vaginal prostaglandins are expensive and well known to cause uterine hyperstimulation which can lead to fetal compromise and even uterine rupture These serious adverse effects are less with oral misoprostol [2,10,11,12,13,14,15,16].
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