RESULTS
We screened 136 women fulfilling primary inclusion criteria. 114 eligible women were randomized, four more than planned in the protocol because four women were discontinued from the study prior to receiving their intervention. Two had a contraindication to the IUD that was not detected in the screening process, and two changed their mind regarding participation after randomization. The two women recruited by error were excluded from the analysis, the two that changed their mind were included in the ITT analysis (n=112). A CONSORT flowchart of participant flow through the study is shown in Figure 1.
Gestational age in the study ranged from 17w1d to 19w6d. By ITT grouping, median gestational age was 19w0d in the immediate group and 19w2d in the delayed arm (p=0.03) which was assessed as clinically insignificant. All other background parameters did not differ statistically between study arms. Overall, women in the study had a median age of 28. Approximately half of participants in both study arms had not completed high school, lived in shacks and were not formally employed, one out of five reported at times going without food. Approximately half had given birth twice or more before. Background and reproductive characteristics of participants according to ITT and PP group are presented in Table 1.
Women received a median of 3 doses (IQR: 2-4 doses) of misoprostol before the abortion was complete (1600 ug). Median time to fetal expulsion was 6.3 hours (IQR: 4.8-9.6 hours) in the immediate arm and 8.3 hours (IQR: 6.0-11.0 hours) in the delayed arm, 40% and 60% respectively had vacuum aspiration for placental remains after the abortion. Median time from fetal expulsion to abortion completion, defined as expulsion or evacuation of the placenta, was 5.2 hours (IQR: 2.9-6.4 hours) in the immediate arm and 4.3 hours (IQR: 1.5-6.5 hours) in the delayed arm. Abortion-related variables were not significantly different between groups.