Analysis
Our main outcomes were assessed after 6 weeks in an intention to treat
(ITT) analysis of all eligible randomized participants (n=112) and a per
protocol (PP) analysis of all participants that were followed up, either
in person, by interview or by record review, according to the
intervention received. Secondary outcomes were assessed at either 6
weeks, 3 months or 6 months post-abortion, according to ITT or PP as
appropriate.
Continuous outcomes were summarized using medians and inter-quartile
range for non-normal distributions and compared group-wise using
Wilcoxon rank-sum (Mann-Whitney) tests. Categorical outcomes were
compared using Chi-squared or Fisher’s Exact test depending on the size
of the subgroup. A sensitivity analysis was performed to control for
uncertainty of data in cases where IUD use was assumed based on
self-report. Analyses were conducted in STATA v. 15, 2019 (StataCorp.
College Station, TX, USA) and significance levels are reported at
p<0.05.