Kopp Kallner 2015.
| Methods | Randomised controlled trail Carried out in 2011‐2012 in Sweden in an outpatient family planning clinic Women who made an appointment by calling the clinic by telephone were informed about the study and invited to participate |
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| Participants | Women were eligible to participate if they: had a gestation of 63 days or less according to their last menstrual period; were 18 years or older; had no contraindication for medical abortion; were in good general health; were not taking any continuing medication for chronic disease | |
| Interventions | 2 nurse midwives experienced in medical abortion and contraceptive counselling received theoretical and practical training in vaginal ultrasound examination of early pregnancy These nurse midwives were the sole providers in the nurse midwife arm There were a total of 34 doctors with varying levels of training and experience in the standard care arm Women randomised to the nurse‐midwife arm were counselled, examined, informed and treated by a single nurse midwife. Nurse‐midwives in this arm did not perform any other tasks during the study period Women randomised to the standard care arm were examined and counselled by the doctor and then received additional information about the practical details and medication from a nurse midwife, according to clinical routine All women received 200 mg of mifepristone in the clinic Women then had the choice of receiving 800 µg of misoprostol vaginally at home or in the clinic 24 to 48 hours after mifepristone administration. If no bleeding occurred within 3 hours, women were instructed to take an additional dose of 400 µg of misoprostol orally Women were followed up after 3 weeks and given a urinary hCG test. If the results were positive a serum hCG test was performed and they were referred for evaluation with vaginal ultrasound Complications were followed up for 6 weeks MLPs and doctors worked at the same site |
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| Outcomes | The primary outcome was efficacy, defined as the need for surgical intervention Secondary outcomes: Safety, defined as no complications up to 6 weeks after the procedure Hospitalisation or blood transfusion Acceptability, defined as women preferring their allocated provider Outcomes were assessed by questionnaires at follow‐up visit |
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| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
| Allocation concealment (selection bias) | Low risk | 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 |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Low loss to follow‐up, similar in each group |
| Selective reporting (reporting bias) | Low risk | Protocol made available prior to study |
| Other bias | Unclear risk | No other bias detected |