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

Phase 2

Terminated

• Conditions: Intra-uterine Residua
• Interventions: Drug: misoprostol

• Registration Number: NCT01134926
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-05-29
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-uterine residua. misoprostol	misoprostol	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.

Primary Outcome Measures

Name	Time	Method
abscence of sonographic finding in the uterine cavity	one week since recruitment	ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width \> 15mm

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HaEmek medical center; 🇮🇱 Afula, Israel