1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [dibyajyotisaikia11@gmail.com].
   


6. For how long will this data be available start date provided 07-08-2027 and end date provided 07-08-2037?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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