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  

Oleh:

Warriner, IK ; Meirik, O ; Hoffman, M. ; Morroni, Chelsea ; Harries, Jane

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The Lancet (keterangan: ada di Proquest) vol. 368 no. 9551 (Dec. 2006), page 1965.

Ketersediaan

Perpustakaan FK Nomor Panggil: L01.K.2006.06 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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 (a=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 Clinicaltrials.gov with the identifier NCT00370487. Findings 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. Interpretation With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.

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