Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Study Overview
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Brief Summary
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Randomizedtrial comparing success and complication rates of operative hysteroscopy versus traditional dilation and curettage (D&C) in the management of first trimester missed abortion.

Detailed Description
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A randomized controlled trial (RCT) of women diagnosed with first trimester spontaneous abortion. Participants interested in operative evacuation of the uterus will be randomized to either operative hysteroscopy or dilation an curettage (D&C). Study population will include pregnant women diagnosed with first trimester spontaneous abortion of up to 13+0 weeks from last menstrual period (LMP) or up to 11+0 weeks of gestation as determined by Crown-Rump Length (CRL). Women who will electively choose to terminate their pregnancy as well as women diagnosed with threatened, incomplete or inevitable abortion will be excluded. All participants will undergo diagnostic hysteroscopy 6-8 weeks after allocated treatment in order to rule out intrauterine adhesion formation and retained product of conception. The primary outcome measure is the risk of intrauterine adhesion formation.

Official Title
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Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion

Conditions
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Spontaneous Abortion, Missed Abortion, Intrauterine Adhesion, Retained Products of Conception

Intervention / Treatment
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* Procedure: Operative Hysteroscopy
* Procedure: D&C
* Procedure: Operative Hysteroscopy - safety and feasibility


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with missed abortion who choose to undergo surgical evacuation. and who are at gestational age of 5+0 weeks to 11+0 weeks from last menstrual period (LMP). Exclusion Criteria: women who electively choose to terminate pregnancy women who took medical treatment for missed abortion prior to recruitment women with known uterine abnormality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Operative Hysteroscopy<br>Hysteroscopic separation | Procedure: Operative Hysteroscopy<br>* Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy<br>|
| Active Comparator: Dilation and Curettage<br>Curettage separation | Procedure: D&C<br>* Separation of the non-viable gestational sac from the uterine wall through dilation and curettage<br>|
| Experimental: Feasibility and safety<br>The first 15 patients recruited will not undergo randomization and will compose the preliminary safety and feasibility phase | Procedure: Operative Hysteroscopy - safety and feasibility<br>* Operative hysteroscopy - safety and feasibility phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrauterine adhesions (IUA) | IUA formation will be assessed in all participants in the follow up diagnostic hysteroscopy performed 8 weeks after the primary treatment. IUA will be classified according to the American Society for Reproductive Medicine | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retained product of conception (RPOC) | RPOC rate in repeat ultrasound scan performed 8 weeks after primary treatment | 2 months |