Efficacy and tolerability of Oral Contraceptive Pills compared to expectant management in retained product of conception: Open-label, outcome- assessor and analyst blinded, parallelly assigned interventional randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Percentage of Participants With complete expulsion of RPOC at end of treatment as determined by TVS
研究概览
简要总结
Rationale
Retained Products of Conception (RPOC) management typically involves expectant management, medical management or surgical management. There are very few drugs used in medical management of RPOC among which misoprostol is most widely used worldwide). However, misoprostol use is associated with significant adverse effects. In many cases, failure of misoprostol in medical termination of pregnancy leads to RPOC. Expectant management is perceived negatively due to its passive nature. Combined oral contraceptives(OCPs) induces endometrial changes conducive to shedding, potentially facilitating RPOC expulsion. OCPs offers a non-surgical alternative, with contraceptive benefits, avoidance of misoprostol-related adverse effects, and psychological acceptability. This could enhance patient acceptance and provide a valuable treatment option before resorting to surgery, particularly in cases where misoprostol is contraindicated or intolerable. While certain retrospective studies and case series tentatively support this conjecture, absence of Randomized Controlled Trials (RCTs) substantiating its efficacy underscores the necessity for further exploration. It could lead to a new indication of an already approved drug.
Objectives
To determine the efficacy of OCPs compared to expectant management in expulsion of RPOC size < 5cm as determined by ultrasonography at the end of one menstrual cycle.
Methods: RCT is proposed to be conducted with a sample size of 106 in each group.
Expected outcome The investigation aims to determine the efficacy of Oral Contraceptive Pills (OCPs) as a therapeutic modality for the medical management of Retained Products of Conception (RPOC). Given the pre-existing approval status of the investigational drug, any observed efficacy could promptly translate into societal benefits without additional costs
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •RPOC on TVS in patients where expectant management is indicated with positive urinary pregnancy test 1 with incomplete miscarriage 2 following medical abortion.
- •3 following surgical evacuation.
排除标准
- •RPOC with any of the following clinical presentations: 1 more than mild vaginal bleeding 2 haemodynamic instability 3 signs of infection and/ or abdominal pain 4 Contraindications for OCP use.
结局指标
主要结局
Percentage of Participants With complete expulsion of RPOC at end of treatment as determined by TVS
时间窗: For Intervention group- Follow up at 4 weeks if no withdrawal | bleeding or 1 week after withdrawal bleeding | For control group- 2 weeks
次要结局
- Percentage of participants requiring D and E at the end of treatment
- Percentage of participants with adverse effects (dizziness, weakness, vomiting, pain abdomen, signs of infection)
研究者
Dr Dibyajyoti Saikia
AllMS, Guwahati