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

HaEmek Medical Center, Israel

Status and phase: Terminated; Phase 2

Conditions: Intra-uterine Residua

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01134926

0014-10-EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

intra-uterine residua. expectant management

No Intervention group

Description:

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

Intra-uterine residua. misoprostol

Experimental group

Description:

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.

Treatment:

Drug: misoprostol