title: Rates of complication in first-trimester manual vacuum aspiration abortion done by doctors and mid-level providers in South Africa and Vietnam: a randomised controlled equivalence trial.
abstract: BACKGROUND
  We assessed whether the safety of first-trimester manual vacuum aspiration abortion done by health-care providers who are not doctors (mid-level providers) is equivalent to that of procedures done by doctors in South Africa and Vietnam, where mid-level providers are government trained and accredited to do first-trimester abortions.
  
  
  METHODS
  We did a randomised, two-sided controlled equivalence trial to compare rates of complication in abortions done by the two groups of providers. An a-priori margin of equivalence of 4.5% with 80% power and 95% CI (alpha=0.05) was used. 1160 women participated in South Africa and 1734 in Vietnam. Women presenting for an induced abortion at up to 12 weeks' gestation were randomly assigned to a doctor or a mid-level provider for manual vacuum aspiration and followed-up 10-14 days later. The primary outcome was complication of abortion. Complications were recorded during the abortion procedure, before discharge from the clinic, and at follow-up. Per-protocol and intention-to-treat analyses were done. This trial is registered at with the identifier .
  
  
  RESULTS
  In both countries, rates of complication satisfied the predetermined statistical criteria for equivalence: rates per 100 patients in South Africa were 1.4 (eight of 576) for mid-level providers and 0 for doctors (difference 1.4, 95% CI 0.4 to 2.7); in Vietnam, rates were 1.2 (ten of 824) for mid-level providers and 1.2 (ten of 812) for doctors (difference 0.0, 95% CI -1.2 to 1.1). There was one immediate complication related to analgesics. Delayed complications were caused by retained products and infection.
  
  
  CONCLUSIONS
  With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.
authors.affiliation: UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, WHO, Geneva 1211, Switzerland. warrineri@who.int
authors.forename: I K
authors.initials: IK
authors.lastname: Warriner
authors.forename: O
authors.initials: O
authors.lastname: Meirik
authors.forename: M
authors.initials: M
authors.lastname: Hoffman
authors.forename: C
authors.initials: C
authors.lastname: Morroni
authors.forename: J
authors.initials: J
authors.lastname: Harries
authors.forename: N T
authors.initials: NT
authors.lastname: My Huong
authors.forename: N D
authors.initials: ND
authors.lastname: Vy
authors.forename: A H
authors.initials: AH
authors.lastname: Seuc
mesh_terms: D000028:Abortion, Induced / Q000009:adverse effects* / Q000379:methods; D000328:Adult; D005260:Female; D006801:Humans; D008875:Middle Aged; D008880:Midwifery / Q000706:statistics & numerical data; D016595:Misoprostol / Q000627:therapeutic use; D010120:Oxytocics / Q000627:therapeutic use; D010823:Physician Assistants / Q000706:statistics & numerical data; D010820:Physicians / Q000706:statistics & numerical data; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D013019:South Africa; D014619:Vacuum Curettage / Q000009:adverse effects* / Q000706:statistics & numerical data; D014744:Vietnam
chemical_list: D010120:Oxytocics; D016595:Misoprostol