Non Surgical Management for Uterine Residua After Pregnancy Termination, Abortion or Delivery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Study Comparing Between Expectant Management and Misoprostol Treatment for Intra-uterine Residua After Pregnancy Termination, Abortion or Delivery|
- abscence of sonographic finding in the uterine cavity [ Time Frame: one week since recruitment ] [ Designated as safety issue: No ]ofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width > 15mm
- Complications [ Time Frame: Within one week since recruitment ] [ Designated as safety issue: Yes ]During the study,there will be collection of data considering pain, bleeding, infection and surgical evacuation.
- Woman's satisfaction [ Time Frame: One week since recruitment ] [ Designated as safety issue: No ]At the end of the week, the patient will be asked about her satisfaction with the treatment
|Study Start Date:||June 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
No Intervention: intra-uterine residua. expectant management
The patients in this arm will not get any treatment and be followed up by US examinations
Experimental: Intra-uterine residua. 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.
8oo mcg intravaginal, second dose after one day if there is no response
Other Name: cytotec
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134926
|HaEmek medical center|
|Principal Investigator:||yfat kadan, MD||haemek medical center|