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

NCT ID: NCT01134926

Last Updated: 2015-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

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.

Conditions

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Intra-uterine Residua

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intra-uterine residua. expectant management

The patients in this arm will not get any treatment and be followed up by US examinations

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

misoprostol

Intervention Type DRUG

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

Interventions

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misoprostol

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

Intervention Type DRUG

Other Intervention Names

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cytotec

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yfat kadan, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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HaEmek medical center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0014-10-EMC

Identifier Type: -

Identifier Source: org_study_id

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