Non Surgical Management for Uterine Residua After Pregnancy Termination, Abortion or Delivery

Study Overview
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Brief Summary
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The aim of the study is to find out whether conservative treatment - expectant management or medical therapy using misoprostol is beneficial in the case of uterine residua, and which treatment is better.

Detailed Description
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Retained products of conception are estimated to occur after approximately 1-6% of pregnancies, probably more often after termination of early pregnancies then after term pregnancy. Complication are abdominal pain, infection, bleeding and for the long term - intrauterine adhesions.Blood clots in the uterine cavity can cause similar complications. The definitive treatment is curettage or hysteroscopy, both of which are carried out under general anesthesia and require an operating theater. Although expectant management and uterotonic drugs are practically used in such situation, they are not described in the literature.This study compare between the outcome of misoprostol treatment and expectant management in the case of intrauterine residua after completion of pregnancy.

Official Title
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Phase Study Comparing Between Expectant Management and Misoprostol Treatment for Intra-uterine Residua After Pregnancy Termination, Abortion or Delivery

Conditions
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Intra-uterine Residua

Intervention / Treatment
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* Drug: misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with sonographic examination reveals suspicion of intra-uterine residua after completion of pregnancy intrauterine cavity, including endometrium, will be at least 15mm Exclusion Criteria: the need for emergency surgical treatment (curettage) fever - at least 38 celsius degree women who had medical termination of pregnancy and the examination is after less then 2 weeks since treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: intra-uterine residua. expectant management<br>The patients in this arm will not get any treatment and be followed up by US examinations | |
| Experimental: Intra-uterine residua. misoprostol<br>The patients in this arm will be treated with misoprostol at the recruitment day. If there will be sonographic evidence of intra-uterine residua the day after, they'll gat another dose. | Drug: misoprostol<br>* 8oo mcg intravaginal, second dose after one day if there is no response<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abscence of sonographic finding in the uterine cavity | ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width > 15mm | one week since recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | During the study,there will be collection of data considering pain, bleeding, infection and surgical evacuation. | Within one week since recruitment | 
| Woman's satisfaction | At the end of the week, the patient will be asked about her satisfaction with the treatment | One week since recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retained products of conception, residua, misoprostol, expectant management