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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01134926
Enrollment
23
Registered
2010-06-02
Start date
2010-06-30
Completion date
2012-05-31
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-uterine Residua

Keywords

Retained products of conception, residua, misoprostol, expectant management

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.

Interventions

DRUGmisoprostol

8oo mcg intravaginal, second dose after one day if there is no response

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
abscence of sonographic finding in the uterine cavityone week since recruitmentofter one week, the patients will undergo an US examination.Failure of management defined as uterine cavity width \> 15mm

Secondary

MeasureTime frameDescription
ComplicationsWithin one week since recruitmentDuring the study,there will be collection of data considering pain, bleeding, infection and surgical evacuation.
Woman's satisfactionOne week since recruitmentAt the end of the week, the patient will be asked about her satisfaction with the treatment

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026