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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01134926
First received: May 29, 2010
Last updated: June 1, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Intra-uterine Residua
Drug: misoprostol
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: misoprostol
8oo mcg intravaginal, second dose after one day if there is no response
Other Name: cytotec

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134926

Locations
Israel
HaEmek medical center Not yet recruiting
Afula, Israel
Contact: Yfat Kadan    972506943426    kadana@orange.co.il   
Principal Investigator: Yfat Kadan, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: yfat kadan, MD HaEmek medical center
  More Information

No publications provided

Responsible Party: Dep. of OB/GYN, HaEmek Medical Center, Dr. Yfat Kadan
ClinicalTrials.gov Identifier: NCT01134926     History of Changes
Other Study ID Numbers: 0014-10-EMC
Study First Received: May 29, 2010
Last Updated: June 1, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Retained products of conception
residua
misoprostol
expectant management

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 25, 2014