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Effectiveness of Early Versus Standard Insertion of Post Abortion Intrauterine Contraception After First Trimester Medical Management of Incomplete Abortion in Central Uganda: A Non-Inferiority Randomized Clinical Trial (PAIC)
Background: Unintended pregnancies continue to cause a public health threat in Low and Middle Income countries yet with restrictive abortion laws. Over 40% of these unintended pregnancies end up as unsafe abortions leading to significant maternal morbidity and mortality. With ovulation occurring between 5-10 days after first trimester abortion, 47% of the women conceive shortly afterwards yet nearly 50% of the women never return for follow up. This study seeks to investigate effectiveness of early insertion of Intrauterine contraception (IUC) (within one week after medical Post abortion care (mPAC)) compared to Standard IUC insertion (between 2-4 weeks post PAC), in Uganda with the ultimate aim of increasing the uptake of IUC post 1st trimester medical management of incomplete abortion. Hypothesis: Null hypothesis: Early Insertion of IUC has higher expulsion rates and continued use than standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Alternate hypothesis: Early Insertion of IUC has similar expulsion rates and continued use as standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%. Methods: A Non-inferiority RCT of 2,076 participants will be conducted in 15 health facilities within Central Uganda. Baseline participant characteristics will be analyzed using descriptive statistics. For continuous variables, statistical tests such as Fisher's exact test, t-test, ANOVA and Wilcoxon-Mann-Whitney test will be used as appropriate. Binary logistic regression model will be used for factors associated with the dependent variable uptake of intrauterine contraception with p-value set \<0.05 as level of significance. Intention to treat and per protocol analysis will be used for the RCTs. Study utility: A greater proportion of women undergoing medical post abortion care for incomplete abortion will receive their intended post abortion IUC within the first days after the PAC treatment compared with routine insertion at a scheduled follow up visit 2-4 weeks later. Though there could be higher expulsion rates in the early versus the standard IUC insertion, continued use at 6 months following abortion will be higher in the early insertion group as compared to the standard insertion group thereby reducing unplanned and unwanted pregnancy.
Details
| Lead sponsor | Makerere University |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 2076 |
| Start date | 2022-06 |
| Completion | 2025-06 |
Conditions
- Incomplete Abortion
- Intrauterine Contraception
- Misoprostol
Interventions
- Use of either copper T380A or Levonorgestrel LNG 52 IUS after medical management of first trimester incomplete abortion
Primary outcomes
- Rate of Continuation of Intrauterine contraceptive use at six months following insertion in both groups evaluated by follow up. — 6 months from insertion of the post abortion intrauterine contraception
The percentage of women who will be still having their IUDs insitu from history and within seven days "Early insertion" or 2-4 weeks "Standard insertion" after medical management of first trimester incomplete abortions. An interviewer administered questionnaire will be used to collect the information and pelvic examination will confirm presence or absence of IUD at every visit. Ultrasound scan will be used in case of any disparity. - Rate of Expulsion of the IUD devices at six months following insertion in both groups evaluated by follow up — 6 months from insertion of the post abortion intrauterine contraception
The percentage of women who will have their IUDs expelled by 6 months out of the total population of women recruited into the study will be defined as "Expulsion rates" either within seven days "Early insertion" or 2-4 weeks "Standard insertion" after medical management of first trimester incomplete abortions. An interviewer administered questionnaire will be used to collect the information and pelvic examination will confirm presence or absence of IUD at every visit. Ultrasound scan will be used in case of any disparity.
Countries
Uganda