Management of RPOC After Induced Abortion

Study Overview
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Brief Summary
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Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion

Detailed Description
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An open label randomized controlled trial (RCT) of all women diagnosed with retained product of conception (RPOC) after first trimester medical TOP in a single university affiliated medical center. All consecutive women who underwent medical TOP by mifepristone and misoprostol at gestational age under 63 days from last menstrual period and were diagnosed with RPOC in a routine 3-week ultrasound follow-up are offered to participate. RPOC is defined as thick irregular endometrium (over 12 mm) with positive Doppler flow. Following recruitment, patients are randomized into either expectant arm or medical arm (800 mcg misoprostol). The primary outcome measure is RPOC rate in repeat ultrasound scan performed 5 weeks after randomization.

Official Title
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Expectant Management Versus Medical Management of Retained Products of Conception After Induced Abortion

Conditions
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Abortion Induced Complicated

Intervention / Treatment
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* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 < age < 45 year old Thick irregular endometrium >12 mm on trans-vaginal ultrasound Exclusion Criteria: Endometritis Cervical opening > 1 cm Uterine abnormalities Contraindication to Misoprostol treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Expectant<br>No medication is assigned. | |
| Experimental: Medical<br>SL 800 mcg Misoprostol | Drug: Misoprostol<br>* sl 800 mcg misoprostol<br>* Other names: Cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RPOC rate | RPOC rate in repeat ultrasound scan performed 5 weeks after randomization | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesions | According to our study protocol all women with persistent products of conception diagnosed on repeated ultrasound examination undergo hysteroscopy. During hysteroscopy, assessment of the uterine cavity including intrauterine adhesion formation will be performed. Intrauterine adhesions will be classified according to the American Society for Reproductive Medicine (ASRM), based on the extent of cavity involvement (<1/3; 1/3 to 2/3, >2/3) and the type of adhesion seen (filmy, filmy and dense, dense). | 2 months | 
| Bleeding | Bleeding pattern will be assessed via questionnaire upon recruitment and follow up visits. Bleeding will be characterized by its pattern (regular, intermenstrual) and quantity (normal, hypomenorrhoea, menorrhagia). | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RPOC, induced abortion, misoprostol