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.