BJOG : an international journal of obstetrics and gynaecology · 2014
The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K
Аннотация
OBJECTIVE: To assess nurse-midwife provision of early medical termination of pregnancy (TOP) in a high-resource setting where ultrasound examination for dating of pregnancy is part of the protocol.
DESIGN: Randomised controlled equivalence trial.
SETTING: Out-patient family planning unit at a university hospital.
POPULATION: Women seeking early medical TOP.
METHODS: A total of 1180 women were randomised, without any prior examination, to counselling, examination, and treatment by either nurse-midwife or gynaecologist. Ultrasound was performed in all cases by the allocated provider.
MAIN OUTCOME MEASURES: The primary outcome was efficacy, defined as the successful completion of TOP without need for vacuum aspiration. Secondary outcomes were safety, defined as need for hospitalisation or blood transfusion, and acceptability, defined as preferred provider were the women to have a medical TOP in the future.
RESULTS: A total of 481 women in the nurse-midwife group and 457 women in the doctor group were available for the final analysis. The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors (risk difference 1.6%, 95% confidence interval 0.2-3.0%, which was within the set margin of equivalence). There were no significant differences in safety parameters. Women examined and counselled by a nurse-midwife were significantly more likely (P < 0.001, 95% confidence interval 0.308-0.394) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future.
CONCLUSIONS: These findings show that nurse-midwife provision of early medical TOP in a high-resource setting, where ultrasound is part of the protocol, is effective, and can be safely implemented with high acceptability among women.
DESIGN: Randomised controlled equivalence trial.
SETTING: Out-patient family planning unit at a university hospital.
POPULATION: Women seeking early medical TOP.
METHODS: A total of 1180 women were randomised, without any prior examination, to counselling, examination, and treatment by either nurse-midwife or gynaecologist. Ultrasound was performed in all cases by the allocated provider.
MAIN OUTCOME MEASURES: The primary outcome was efficacy, defined as the successful completion of TOP without need for vacuum aspiration. Secondary outcomes were safety, defined as need for hospitalisation or blood transfusion, and acceptability, defined as preferred provider were the women to have a medical TOP in the future.
RESULTS: A total of 481 women in the nurse-midwife group and 457 women in the doctor group were available for the final analysis. The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors (risk difference 1.6%, 95% confidence interval 0.2-3.0%, which was within the set margin of equivalence). There were no significant differences in safety parameters. Women examined and counselled by a nurse-midwife were significantly more likely (P < 0.001, 95% confidence interval 0.308-0.394) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future.
CONCLUSIONS: These findings show that nurse-midwife provision of early medical TOP in a high-resource setting, where ultrasound is part of the protocol, is effective, and can be safely implemented with high acceptability among women.