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

This study has been terminated.
(The principal investigator left the organization)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01134926
First Posted: June 2, 2010
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HaEmek Medical Center, Israel
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    At the end of the week, the patient will be asked about her satisfaction with the treatment


Enrollment: 23
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134926


Locations
Israel
HaEmek medical center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: yfat kadan, MD haemek medical center
  More Information

Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01134926     History of Changes
Other Study ID Numbers: 0014-10-EMC
First Submitted: May 29, 2010
First Posted: June 2, 2010
Last Update Posted: June 23, 2015
Last Verified: June 2015

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
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics


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