title: No benefit, but increased harm from high dose (100 microg) misoprostol for induction of labour: a randomised trial of high vs. low (50 microg) dose misoprostol.
abstract: Misoprostrol, a synthetic analogue of prostaglandin E(1), has been used for cervical preparation. Its ideal dose, route and frequency of administration are still under investigation. We conducted a randomised controlled trial, in a tertiary hospital in a developing country, to compare misoprostol 50 microg (low) and 100 microg (high) for effectiveness and safety in induction of labour at term. Women admitted for induction of labour with a singleton live fetus in cephalic presentation after 37 weeks' gestation were recruited. A misoprostol tablet was inserted in the posterior vaginal fornix at 8-hour intervals. Main outcomes were duration of induction, maternal and fetal complications. The mean duration of induction was 15.4 (SD 10.6) and 14.2 (SD 13.6) h in the low- and high-groups respectively (P = 0.095). There was no difference in need for augmentation with oxytocin (OR 0.82; 95% Cl 0.36-1.86) or operative delivery (OR 1.29; 95% CI 0.26-6.84). There were two uterine ruptures and four intrapartum stillbirths in the high misoprostol group. There was no difference in postpartum haemorrhage, 9.5% vs. 7.9% (P = 1.00) and admissions to the neonatal unit 18.8% vs. 17.0% (P = 0.980) in the 1ow- and high-groups) respectively. Misoprostol 50 microg was as effective as the 100 microg dose for induction of labour whereas the higher dose had an increased risk of serious complications.
authors.affiliation: Department of Obstetrics and Gynaecology, University of Zimbabwe Medical School, Harare, Zimbabwe. majokof215@avu.org
authors.forename: F
authors.initials: F
authors.lastname: Majoko
authors.forename: L
authors.initials: L
authors.lastname: Nystrom
authors.forename: G
authors.initials: G
authors.lastname: Lindmark
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000009:adverse effects*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D016037:Single-Blind Method
chemical_list: D010120:Oxytocics; D016595:Misoprostol