Warriner 2011.
| Methods | Randomised controlled trial. Multicentre randomised controlled equivalence trial, which took place over 11 months Sequence generation: Computer‐generated randomisation scheme stratified by study centre with a block size of 6. The random allocation sequence was generated by the use of SAS software (SAS Institute, Cary, NC, USA) Allocation sequence concealment: Sealed, opaque envelopes containing the random allocation were consecutively numbered and were opened and assigned sequentially to women by a research assistant once written informed consent had been obtained Blinding: blinded to research assistant |
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| Participants | 1032 women completed the study in 5 rural district hospitals in Nepal. Data were collected between 15 April 2009 and 17 March 2010 Eligibility: Providers: only providers trained in manual vacuum aspiration were eligible for medical abortion training Patients: less than 9 weeks (≤ 63 days) of gestation according to date of last menstrual period and as estimated by bimanual pelvic examination, older than 16 years, resided no more than 90 minutes journey from the study clinic and willing to be randomly assigned to a provider, to return to the clinic 10 to 14 days after the start of treatment and to provide written informed consent |
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| Interventions | Medical abortion regimen of 200 mg mifepristone orally followed by 800 mg of misoprostol vaginally 1 to 2 days later, delivered by MLPs (staff nurses and auxiliary midwives) trained in MVA, or doctors (obstetricians, gynaecologists, general practitioners and other doctors) across 5 district hospitals in Nepal. Women were followed up 10 to 14 days after the procedure MLPs and doctors worked from the same site, though waiting areas and examination rooms were separated to reduce interaction between providers |
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| Outcomes | The primary endpoint was complete abortion without manual vacuum aspiration within 30 days of treatment Failed abortion (continuing pregnancy) was recorded when clinical examination indicated continuing symptoms of pregnancy and manual vacuum aspiration was needed to terminate the pregnancy Incomplete abortion was defined as products of conception remaining in the uterus with continued bleeding, bulky uterus and open cervix at examination, possibly necessitating surgical evacuation at the discretion of the provider or at the woman's request Women were also asked whether they had visited any non‐study hospital, clinic or provider during the study The secondary endpoint measured case management decisions by recording case management discussion and referrals between providers to assess the extent to which each group provided medical abortion services independently Serious adverse events (haemorrhage necessitating blood transfusion, conditions necessitating hospitalisation) were recorded |
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| Notes | A limitation of the study is that although separate waiting and examination rooms for the 2 groups were set up for the duration of the study, both types of providers worked in the same hospital and in the same environment. Although this controlled environment optimised comparison, it might have led to a convergence of outcomes that would not have happened if the women had been assigned to providers at different clinics | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generation using SAS |
| Allocation concealment (selection bias) | Low risk | Sequential, sealed, opaque envelopes |
| 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 study |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding Outcome was assessed by the same provider type that carried out the abortion – potentially the same provider Observer bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up of women receiving treatment was 24 of 542 (4%) in the mid‐level health care providers group and 19 of 535 (4%) in the doctors group. Women lost to follow‐up were, on average, less educated than those followed up. Two women in the doctors group were excluded from the analysis because at follow‐up they were shown not to have been pregnant: one was a long‐time user of a 3‐monthly injectable contraceptive, and the other one had had a manual vacuum aspiration 37 days before |
| Selective reporting (reporting bias) | Unclear risk | Protocol not published |
| Other bias | Low risk | The study appears to be free of other sources of bias |