Jejeebhoy 2011.
| Methods | Cohort study The study was located in 5 clinics in Bihar and Jharkhand, 2 poorly developed states of India, in which access to health services is limited |
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| Participants | 865 women completed the study Eligibility: Positive uterine pregnancy of ≤ 10 weeks gestational age; no attempts in the previous week to terminate the current pregnancy; resided within an hour of the study; willing to return 7 days later (day 7) for a follow‐up check‐up and undergo 2 pelvic examinations (by the study provider and supervisor); indicated no other contraindications for abortion as per the Government of India guidelines |
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| Interventions | MVA delivered by nurses or physicians with no previous experience of providing any type of abortion, who underwent MVA training as part of the study All abortion procedures were conducted in the presence of a qualified supervisor Women were followed up after 7 days |
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| Outcomes | Provider assessment of gestational age Provider assessment of other criteria relating to eligibility Provider assessment of complete abortion Efficacy: complete abortion at day 7 Overall complication rate: including failure (failed abortion and adverse events ‐ blood transfusion, cervical injury, perforation, bowl injury, infection, hospitalisation) |
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| Notes | Supervisor assessment of outcomes Women attending the clinics were unaware of the type of provider prior to attending the clinic. The authors state that recruitment was naturally random |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No random sequence generation. Providers were assigned to a facility for a certain period of time. Clients who came for an abortion were unaware of the type of clinician who would be providing services on the day of the visit |
| Allocation concealment (selection bias) | High risk | None specified |
| 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 | None specified |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available – the report alludes to a protocol and summarises it in the methods but there is no published protocol |
| Other bias | Low risk | The study appears to be free of other sources of bias |