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WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. [Estudio clínico multicéntrico aleatorizado de la OMS sobre misoprostol en el manejo del alumbramiento]
Lancet. 2001 Sep 1; 358(9283):689-95.Postpartum hemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labor, including use of uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. The authors did a multicenter, double- blind, randomized controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labor. In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, the authors randomly assigned women about to deliver vaginally to receive 600 mcg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labor. The primary outcomes were measured postpartum blood loss of 1000 ml or more, and the use of additional uterotonics without an unacceptable level of side-effects. The authors chose an upper limit of a 35% increase in the risk of blood loss of 1000 ml or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 ml or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% confidence interval 1.19-1.63], p < 0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p < 0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15- 3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 mcg oral misoprostol in the active management of the third stage of labor in hospital settings where active management is the norm. (author's)
Multinational comparative clinical trial of long-acting injectable contraceptives: norethisterone enanthate given in two dosage regimens and depot-medroxyprogesterone acetate. A preliminary report.
Contraception. 1982 Jan; 25(1):1-11.A multicenter phase 3 clinical trial compared norethisterone enanthate (NET-EN) given by 2 different treatment regimens and depot-medroxyprogesterone acetate (DMPA). After 18 months of observation, preliminary findings are reported for 790 women who received NET-EN 200 mg every 60 days; for 796 women who recieved NET-EN every 60 days (200 mg) for 6 months, then 200 mg every 84 days, and for 1589 women who received DMPA 150 mg every 90 days. Overall discontinuation rates and discontinuation for bleeding and personal reasons were similar for all 3 groups after 18 months observation (61.8-63.5/100 women). Terminations due to amenorrhea were significantly higher among DMPA users (12.1 and 17.4/100 women at 12 and 18 months) than among both NET-EN groups (6.8-8.2/100 women at 12 months and 10.4-10.9/100 women at 18 months). The only significant difference in pregnancy rates observed among the 3 groups was a higher rate at 18 months among NET-EN (84 days) users (1.6/100 women), than among DMPA users (0.2/100 women). There was no overall significant difference between the 2 NET-EN groups, although between the 6 and 18 month follow-ups when the 2 NET-EN regimens diverged, the NET-EN (84 days) users' pregnancy rates rose significantly, whereas in the NET-EN (60 days) group, the pregnancy rate did not change. Weight gain was significantly higher in those subjects using NET-EN at 60 day intervals than at 84-day intervals. (author's modified)