WHO multicentre randomised trial of misoprostol in the management of the third stage of labour

被引:235
作者
Gülmezoglu, AM
Villar, J [1 ]
Ngoc, NTN
Piaggio, G
Carroli, G
Adetoro, L
Abdel-Aleem, H
Cheng, LN
Hofmeyr, GJ
Lumbiganon, P
Unger, C
Prendiville, W
Pinol, A
Elbourne, D
El-Refaey, H
Schulz, KF
机构
[1] WHO, Dept Reprod Hlth & Res, UNDP,UNFPA, World Bank Special Programme Res Dev & Res Traini, CH-1211 Geneva 27, Switzerland
[2] Hung Vuong Obstet & Gynaecol Hosp, Ho Chi Minh City, Vietnam
[3] Ctr Rosarino Estud Perinatales, Rosario, Santa Fe, Argentina
[4] Ctr Res Reprod Hlth, Shagamu, Nigeria
[5] Assiut Univ Hosp, Dept Obstet & Gynaecol, Assiut, Egypt
[6] Int Peace Matern & Child Hlth Hosp, Shanghai, Peoples R China
[7] Univ Witwatersrand, Effect Care Res Unit, Johannesburg, South Africa
[8] Khon Kaen Univ, Dept Obstet & Gynaecol, Khon Kaen, Thailand
[9] Univ Zurich, Dept Obstet & Gynaecol, Zurich, Switzerland
[10] Limmattal Hosp, Zurich, Switzerland
[11] Coombe Lying In Hosp, Dublin 8, Ireland
[12] London Sch Hyg & Trop Med, London WC1, England
[13] Chelsea & Westminster Hosp, Imperial Coll Sch Med, London, England
[14] Univ N Carolina, Dept Obstet & Gynecol, Chapel Hill, NC 27515 USA
关键词
D O I
10.1016/S0140-6736(01)05835-4
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin Ell. 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. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour. Methods In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 mug 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 labour. 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. We 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. Findings 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% CI 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. Interpretation 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 mug oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.
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页码:689 / 695
页数:7
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