Mate Whenua—Follow‐Up After Early Medical Abortion in New Zealand: A Randomised Controlled Trial

OBJECTIVE: To evaluate self-assessment with low sensitivity urine pregnancy test versus comparative serum bhCG in women having early medical abortion (EMA) for the outcomes of complete follow-up and ongoing live pregnancy. DESIGN: Multi-centre parallel group randomised controlled trial. SETTING: Six abortion services in Aotearoa New Zealand. POPULATION: Pregnant women having EMA. METHODS: Participants were randomised on a 1:1 ratio, stratified by centre, to a follow up protocol, self-assessment, or blood tests. Chi-squared tests, relative risks, and absolute risk differences (with 95% confidence intervals) were calculated. MAIN OUTCOME MEASURES: Primary outcome was complete follow-up (able to discuss follow-up test result within 6 weeks). Secondary outcomes were successful abortion; contraception; complications; and additional services. RESULTS: There were 732 participants. More participants in the self-assessment group had complete follow-up compared to the blood test group (94.5% vs. 67.4%, p < 0.001; relative risk (RR) 1.41 [95% confidence interval (CI) 1.30-1.52]). More participants in the self-assessment group had a successful EMA (89.0% vs. 81.0%, p = 0.002; RR 1.10 [95% CI: 1.03-1.17]) and more additional follow up investigations (17.3% vs. 11.1%, p = 0.017; RR 1.55 [95% CI: 1.08-2.24]). There were no differences between groups in contraception (61.0% vs. 56.0%; RR 1.09 [95% CI: 0.96-1.23]), additional health care visits (11.% vs. 10.3%; RR 1.06 [95% CI: 0.70-1.62]), community prescriptions (4.4% vs. 5.2%; RR 0.85 [95% CI: 0.44-1.63]) or complications (8.5% vs. 8.7%; RR 1.09 [95% CI: 0.96-1.23]). There was one ongoing live pregnancy detected after the first trimester. CONCLUSIONS: The authors recommend self-assessment after EMA for improved follow-up. In addition to demonstrating clinical effectiveness and safety, the findings have important implications for improving reproductive health equity. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000890639 (registered prospectively on 21/08/2023; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384373&isClinicalTrial=False).