Intention to treat
The ITT analysis included all eligible randomized women (n=112), 55 women in the immediate arm and 57 women in the delayed arm (Table 2). In the immediate arm, 45 women (82%) received the IUD as planned. Median time from abortion completion until IUD insertion was 12.7 hours (IQR 3.8-18.5 hours). Eight women crossed over to the delayed arm because of a contraindication to immediate IUD insertion post-abortion (n=5), patient request (n=2) or protocol deviation (n=1). Two women changed their mind about study participation and were discontinued. Out of 57 women randomized to the delayed arm, 12 (21%) had the IUD inserted as planned. The remaining 45 (79%) either did not go to their 3-week appointment at the CHC (n=35), went to the CHC but did not receive an IUD (n=3), or changed their mind about having an IUD (n=7).
Use of the original IUD at 6 weeks was 56% in the immediate group and 19% in the delayed group (p<0.001). At the end of the 6-week follow-up period, 42 women (76%) in the immediate arm, and 23 (40%) in the delayed arm were using the original or a replacement IUD (p<0.001). At 3 months, use of the original, or any IUD, was 49% and 69% in the immediate group and 18% and 37% in the delayed group, respectively. Corresponding figures at 6 months were 40% and 55%, and 14% and 26%, respectively. Decreasing rates for use were mostly due to loss-to-follow-up (LTFU); 1 woman in the immediate arm and 1 in the delayed arm reported that they had the IUD removed between the 6 week and 6 month follow-up. Two women had a recurrent pregnancy in the 6 months following the abortion, both followed the delayed arm protocol.
In the sensitivity analysis we categorized self-reported use in the immediate group not corroborated by ultrasound (n=2) as “non-use” instead of “use”, and self-reported use not corroborated by medical records at 6 weeks in the delayed group as “use” instead of “non-use”. This resulted in 51% and 26% (p=0.01) use of the original IUD at six weeks in the immediate arm and the delayed arm respectively. In a sub-analysis of women in the immediate arm, we found that expulsion or removal rate of the IUDs inserted after vacuum aspiration was not significantly different from those inserted without vacuum aspiration (32% vs. 29%, p=0.81).