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

Intra-uterine Residua Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134926
• Other study ID #: 0014-10-EMC
• Status: Terminated
• Phase: Phase 2
• First received: May 29, 2010
• Last updated: June 21, 2015
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intra-uterine Residua

Intervention

Drug:
• misoprostol
8oo mcg intravaginal, second dose after one day if there is no response

Locations

Country	Name	City	State
Israel	HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Complications	During the study,there will be collection of data considering pain, bleeding, infection and surgical evacuation.	Within one week since recruitment	Yes
Secondary	Woman's satisfaction	At the end of the week, the patient will be asked about her satisfaction with the treatment	One week since recruitment	No