Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal

摘要: Summary Background Medical abortion is under-used in developing countries. We assessed whether early first-trimester medical provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe effective that doctors Nepal. Methods This multicentre randomised controlled equivalence trial done five rural district hospitals Women were eligible for if their pregnancy of less than 9 weeks (63 days) they resided 90 min journey away from the study clinic. ineligible had any contraindication to abortion. used a computer-generated randomisation scheme stratified centre with block size six. randomly assigned doctor or provider oral administration 200 mg mifepristone followed 800 μg misoprostol vaginally 2 days later, up 10–14 later. The primary endpoint complete without manual vacuum aspiration within 30 treatment. not masked. Abortions recorded complete, incomplete, failed (continuing pregnancy). Analyses secondary endpoints intention treat, supplemented per-protocol analysis endpoint. registered ClinicalTrials.gov, NCT01186302. Findings Of 1295 women screened, 535 542 provider. 514 518, respectively, included analyses judged 504 (97·3%) 494 (96·1%) physicians. risk difference 1·24% (95% CI −0·53 3·02), which falls predefined range (−5% 5%). Five cases (1%) cohort none cohort; remaining incomplete abortions. No serious complications noted. Interpretation provision weeks' gestation similar safety effectiveness. Where permitted law, appropriately trained health-care can provide safe, low-technology services independently doctors. Funding UNDP/UNFPA/WHO/World Bank Special Programme Research, Development Research Training Human Reproduction (HRP), Department Reproductive Health (RHR), World Organization.