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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,076
- 试验地点
- 1
- 主要终点
- Rate of Continuation of Intrauterine contraceptive use at six months following insertion in both groups evaluated by follow up.
研究概览
简要总结
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.
详细描述
Rationale for study:
Early IUC insertions post first trimester medical abortion management avails the opportunity of utilizing the limited human resource in low resource setting. Prior studies have shown higher continuation rates and patient satisfaction with early IUC than with the standard insertion between 2-4 weeks after medical PAC. There's also no need for back up contraception with early IUC as implemented for standard IUC.
Objective: To compare the expulsion rates and continuation rates at six months between early IUC and standard IUD insertions among women managed with mPAC after first trimester incomplete abortion.
Null hypothesis: Early Insertion of IUC has higher expulsion and continued use rates 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 and continued use rates as standard insertion after medical management among women with first trimester incomplete abortion at six months within a non-inferiority margin of 7.5%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women eligible for medical management of first trimester incomplete abortion,
- •Staying within ten kilometres from the health facility,
- •Opting for post abortion IUC with no intention of conceiving within one year,
- •Able and willing to comply with the planned follow up.
排除标准
- •Women with known allergies to copper or Levonorgestrel IUDs,
- •Patients with unsafe or septic abortions,
- •Confirmed cervical cancer or with suspicious Pap smear cytology results demanding more work up,
- •Hemoglobin level below 9 g/dl,
- •Active genital tract infections,
- •Coagulopathies,
- •Known uterine anomalies,
- •Suspected ectopic pregnancies
- •Women with mental health issues that make it hard for them to comprehend the study protocols will be offered the standard of care but will be excluded from the study.
结局指标
主要结局
Rate of Continuation of Intrauterine contraceptive use at six months following insertion in both groups evaluated by follow up.
时间窗: 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
时间窗: 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.
次要结局
- Ease of IUD insertion(immediately after the procedure of insertion)
- Discontinuation rates(This will at 6 and 12 months after the IUD placement)
- Pregnancy rates(12 months after IUD insertion)
- Pain at IUD insertion(immediately after the IUD insertion procedure)