Introduction This trial reports on use of the copper intrauterine device (IUD) after immediate compared with delayed insertion following medical abortion at 17–20 gestational weeks (GW).
Methods This randomised controlled trial was conducted at one tertiary hospital and five community healthcare centres in Cape Town, South Africa. Eligible consenting women were randomised to immediate (within 24 hours) or delayed (3 weeks post-abortion) insertion of the copper IUD. Follow-up was at 6 weeks, 3 months and 6 months. Main outcomes were use of the original IUD and use of any IUD, including replacement IUDs at 6 weeks post-abortion. Secondary outcomes included rates of expulsion and malposition at 6 weeks, use of any IUD at 3 and 6 months, and acceptability of the IUD.
Results We recruited and randomised 114 women admitted for elective medical abortion between August 2018 and June 2019. In the immediate and delayed study arms, respectively, 45/55 (82%) and 12/57 (21%) women received the IUD as planned. By intention-to-treat, 56% in the immediate and 19% in the delayed arms were using the original IUD at 6 weeks (p<0.001), and 76% in the immediate and 40% in the delayed arms were using any IUD (p<0.001). Complete expulsion or removal occurred in 32% in the immediate and 7% in the delayed arms (p=0.044).
Conclusions Insertion of an IUD immediately after medical abortion at 17–20 GW results in increased use after 6 weeks compared with delayed insertion, however expulsion rates are higher than with interval insertion.
Clinical trials registration NCT03505047), Pan African Trials Registry (www.pactr.org), 201804003324963
- contraceptive Effectiveness
- intrauterine devices
- randomised controlled trial
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DC and ME are shared first author.
Contributors DC was the principal investigator from proposal writing up to final write up. ME was the co-principal investigator from research design up to final write up. DG participated in study design, analysis, manuscript preparation and editing. GP participated in study execution, manuscript preparation and editing. MP participated in study execution, manuscript preparation and editing.
Funding This study was funded by Anonymous donor (5290); National Research Foundation of South Africa/Swedish Foundation for International Cooperation in Research and Higher Education (170825260615/112631), Swedish Society of Medicine (SLS-783181), Swedish Society of Medical Research (P17-0214).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. De-identified participant data will be made available on request by the first lead author, Dr Deborah Constant (email@example.com). Re-use of data is permissible for secondary analysis. Additional information available on request includes the study protocol and CRFs.
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