Warriner 2006.
| Methods | Randomised controlled trial The study was carried out in South Africa from September 2003 to June 2004 and in Vietnam from May to December 2003 Randomisation was done separately for each clinic using a block design with about 600 women in each centre and a ratio of 1:1 for doctors and MLPs. The random allocation sequence was generated using SAS by a data management team at WHO in Geneva, Switzerland Sealed, opaque envelopes containing the random allocation of the type of provider were sequentially numbered and were opened when written informed consent had been provided Women were not blinded to their provider type |
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| Participants | 1153 women completed the study in South Africa. All women presenting for an abortion at 2 MSI clinics in the Western Cape Province and 2 MSI clinics in KwaZulu Natal province were invited to take part if they met the eligibility criteria 1636 women completed the study in Vietnam. All women presenting for an abortion at 4 MSI clinics in Ha Tinh, Ho Chi Minh City, Nghe An and Thai Binh were invited to take part in the study if they met the eligibility criteria Clinics in both countries were located in urban and peri‐urban areas and served mainly lower middle‐class women Eligibility criteria: All women who presented for a first‐trimester abortion during the study period were informed of the study and invited to participate Women met medical eligibility criteria if they were: at least 18 years old; the gestational age of the pregnancy was less than 12 completed weeks as estimated by pelvic examination and date of last menstrual period Data from ultrasound examinations, done routinely at MSI clinics, were also obtained to ensure that eligibility criteria were met Additional eligibility criteria were: residence within a specified geographical area; willingness to be randomly assigned to a provider; willingness to return to the clinic for follow‐up or to be interviewed at home (or another mutually agreed upon location) or by telephone, 10 to 14 days after the abortion. Additionally, women were required to provide written informed consent Gestation < 12 weeks assessed by ultrasound |
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| Interventions | MVA delivered by MLPs with government‐accredited training in abortion, and those administered by physicians. All participants were offered lidocaine and additional oral analgesia; in one of the study locations (South Africa), misoprostol 400 mg was administered 2 to 3 hours before the procedure (reference). Women were followed up 10 to 14 days after the procedure MLPs and doctors worked at the same site |
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| Outcomes | Compared outcomes of MVA procedures for pregnancies up to 12 weeks gestation delivered by MLPs with government‐accredited training in abortion and those procedures administered by physicians Abortion complications (i) Collected at the time of abortion/before leaving clinic and at follow‐up 10 to 14 days later (ii) Reported: at follow‐up interviews Immediate complications: excess bleeding (> 500 cc) after abortion, cervical injury, confirmed/suspected perforation, adverse drug reaction Delayed complication: retained POC needing re‐evacuation, haematometra, post‐abortion pelvic infection, excessive post‐abortion bleeding (> 500 cc), abortion‐related death Percentage of complication types per group |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate randomisation: "computer generated randomisation list" |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes; opened once written informed consent obtained |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participant was aware of the provider type. We do not consider this to be a bias because this is part of the intervention. If MLPs are to perform abortion procedures outside of study conditions, we would expect patients to be aware of the provider type. We therefore do not consider the lack of blinding to provider type to bias the results of the studys |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Interviewer was a 3rd party, however they were not blinded to the provider type |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low |
| Selective reporting (reporting bias) | Unclear risk | Pre‐specified outcomes were reported; protocol not published |
| Other bias | Low risk | The study appears to be free of other sources of bias |