H Kopp Kallner1, R Gomperts, E Salomonsson, M Johansson, L Marions, K Gemzell-Danielsson. 1. Division of Obstetrics and Gynaecology, Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden; Department of Obstetrics and Gynaecology, Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Abstract
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.
RCT Entities:
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.
Authors: Wendy V Norman; Edith R Guilbert; Christopher Okpaleke; Althea S Hayden; E Steven Lichtenberg; Maureen Paul; Katharine O'Connell White; Heidi E Jones Journal: Can Fam Physician Date: 2016-04 Impact factor: 3.275
Authors: Susanne Sjöström; Helena Kopp Kallner; Emilia Simeonova; Andreas Madestam; Kristina Gemzell-Danielsson Journal: PLoS One Date: 2016-06-30 Impact factor: 3.240