Kevin Sunde Oppegaard1, Erik Qvigstad2, Christian Fiala3, Oskari Heikinheimo4, Lina Benson5, Kristina Gemzell-Danielsson6. 1. Department of Gynaecology, Helse Finnmark, Klinikk Hammerfest, Hammerfest, Norway. Electronic address: kevinsunde@hotmail.com. 2. Faculty of Medicine, University of Oslo, Oslo, Norway; Deparment of Gynaecology, Women and Children's Division, Ullevål University Hospital, Oslo, Norway. 3. GynMed Clinic, Vienna, Austria; Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. 4. Department of Obstetrics and Gynaecology, University of Helsinki, Helsinki, Finland; Kätilöopisto Hospital/Helsinki University Central Hospital, Helsinki, Finland. 5. Department of Clinical Science and Education, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. 6. Department of Women's and Children's Health, Division of Obstetrics and Gynaecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
Abstract
BACKGROUND: Medical abortion with mifepristone and prostaglandins is well established. We compared clinical assessment with self-assessment of abortion outcome. METHODS: This randomised, controlled, non-inferiority trial was done in four clinics in Austria, Finland, Norway, and Sweden, between Aug 16, 2011, and Jan 31, 2013. Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation were eligible. Computer-generated block randomisation (block size ten) assigned women in a 1:1 ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin (hCG) test 1-3 weeks after abortion. The primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within 3 months. Analysis was per protocol and by intention to treat. The non-inferiority margin was five percentage points. This trial is registered with ClinicalTrials.gov, number NCT01487213. FINDINGS:924 women were assigned routine follow-up (n=466) or self-assessment (n=458) and included in the intention-to-treat analysis. 901 were included in the per-protocol analysis (n=446 and n=455, respectively). Complete abortion was reported in 432 (95%) of 455 in the routine follow-up group and 419 (94%) of 446 women in the self-assessment group (crude difference -1·0, 95% CI -4·0 to 2·0). 20 (4%) women in the routine follow-up group and 17 (4%) in the self-assessment group required surgery. No women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies. Eight (1·8%) and one (0·2%) women, respectively, had infections (p=0·038). INTERPRETATION: Self-assessment was non-inferior to routine follow-up and could save resources. FUNDING: Nordic Federation of Obstetrics and Gynaecology, European Society of Contraception, Helsinki University Central Hospital, Helse Finnmark, Swedish Research Council, and Stockholm County Council and Karolinska University Hospital.
RCT Entities:
BACKGROUND: Medical abortion with mifepristone and prostaglandins is well established. We compared clinical assessment with self-assessment of abortion outcome. METHODS: This randomised, controlled, non-inferiority trial was done in four clinics in Austria, Finland, Norway, and Sweden, between Aug 16, 2011, and Jan 31, 2013. Women aged 18 years and older who had requested medical termination of a pregnancy up to 63 days of gestation were eligible. Computer-generated block randomisation (block size ten) assigned women in a 1:1 ratio to attend routine clinical follow-up or to self-assess outcome at home with a semiquantitative urine human chorionic gonadotropin (hCG) test 1-3 weeks after abortion. The primary outcome was the percentage of women with complete abortion not requiring further medical or surgical intervention within 3 months. Analysis was per protocol and by intention to treat. The non-inferiority margin was five percentage points. This trial is registered with ClinicalTrials.gov, number NCT01487213. FINDINGS: 924 women were assigned routine follow-up (n=466) or self-assessment (n=458) and included in the intention-to-treat analysis. 901 were included in the per-protocol analysis (n=446 and n=455, respectively). Complete abortion was reported in 432 (95%) of 455 in the routine follow-up group and 419 (94%) of 446 women in the self-assessment group (crude difference -1·0, 95% CI -4·0 to 2·0). 20 (4%) women in the routine follow-up group and 17 (4%) in the self-assessment group required surgery. No women in the routine follow-up group versus three in the self-assessment group had undetected continuing pregnancies. Eight (1·8%) and one (0·2%) women, respectively, had infections (p=0·038). INTERPRETATION: Self-assessment was non-inferior to routine follow-up and could save resources. FUNDING: Nordic Federation of Obstetrics and Gynaecology, European Society of Contraception, Helsinki University Central Hospital, Helse Finnmark, Swedish Research Council, and Stockholm County Council and Karolinska University Hospital.
Authors: Regina M Renner; Madeleine Ennis; Damien Contandriopoulos; Edith Guilbert; Sheila Dunn; Janusz Kaczorowski; Elizabeth K Darling; Arianne Albert; Claire Styffe; Wendy V Norman Journal: CMAJ Open Date: 2022-09-27
Authors: Mandira Paul; Sharad D Iyengar; Birgitta Essén; Kristina Gemzell-Danielsson; Kirti Iyengar; Johan Bring; Marie Klingberg-Allvin Journal: BMC Public Health Date: 2016-10-17 Impact factor: 3.295