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Two Mifepristone Doses and Two Intervals of Misoprostol Administration for Termination of Early Pregnancy : A Randomised Factorial Controlled Equivalence Trial

von Hertzen, H.; Piaggio, G.; Wojdyla, D.; Marions, L.; My Huong, N. T.; Tang, O. S.; Fang, A. H.; Wu, S. C.; Kalmar, L.; Mittal, S.; Erdenetungalag, R.; Horga, M.; Pretnar-Darovec, A.; Kapamadzija, A.; Dickson, K.; Anh, N. D.; Tai, N. V.; Tuyet, H. T.; P
Fonte: Banco Mundial Publicador: Banco Mundial
Tipo: Artigo de Revista Científica
EN
Relevância na Pesquisa
36.43%
OBJECTIVE: To compare the efficacy of 100 mg and 200 mg of mifepristone and 24- and 48-hour intervals to administration of 800 microg vaginal misoprostol for termination of early pregnancy. DESIGN: Placebo-controlled, randomized, equivalence trial, stratified by centre. SETTING: 13 departments of obstetrics and gynecology in nine countries. POPULATION: 2,181 women with 63 days or less gestation requesting medical abortion. METHODS: Two-sided 95% CI for the risk differences of failure to complete abortion were calculated and compared with 5% equivalence margin between two doses of mifepristone and two intervals to misoprostol administration. Proportions of women with adverse effects were compared between the regimens using standard testes for proportions. OUTCOME MEASURES: Rates of complete abortion without surgical intervention and adverse effects associated with the regimens. RESULTS: Efficacy outcome was analysed for 2,126 women (97.5%) excluding 55 lost to follow up. Both mifepristone doses were found to be similar in efficacy. The rate of complete abortion was 92.0% for women assigned 100 mg of mifepristone and 93.2% for women assigned 200 mg of mifepristone (difference 1.2%, 95% CI: -1.0 to 3.5). Equivalence was also evident for the two intervals of administration: the rate of complete abortion was 93.5% for 24-hour interval and 91.7% for the 48-hour interval (difference -1.8%...

Can Midlevel Health-Care Providers Administer Early Medical Abortion as Safely and Effectively as Doctors? A Randomised Controlled Equivalence Trial in Nepal; Lancet

Warriner, I. K.; Wang, D.; Huong, N. T.; Thapa, K.; Tamang, A.; Shah, I.; Baird, D. T.; Meirik, O.
Fonte: Banco Mundial Publicador: Banco Mundial
Tipo: Journal Article; Journal Article
EN
Relevância na Pesquisa
36.58%
BACKGROUND: Medical abortion is under-used in developing countries. We assessed whether early fi rst-trimester medical abortion provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe and effective as that provided by doctors in Nepal. METHODS: This multicentre randomised controlled equivalence trial was done in fi ve rural district hospitals in Nepal. Women were eligible for medical abortion if their pregnancy was of less than 9 weeks (63 days) and if they resided less than 90 min journey away from the study clinic. Women were ineligible if they had any contraindication to medical abortion. We used a computer-generated randomisation scheme stratified by study centre with a block size of six. Women were randomly assigned to a doctor or a midlevel provider for oral administration of 200 mg mifepristone followed by 800 mug misoprostol vaginally 2 days later, and followed up 10-4 days later. The primary endpoint was complete abortion without manual vacuum aspiration within 30 days of treatment. The study was not masked. Abortions were recorded as complete, incomplete, or failed (continuing pregnancy). Analyses for primary and secondary endpoints were by intention to treat, supplemented by per-protocol analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov...