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NCT01723605 Clinical Trial

Insitu Repair Versus Uterine Exeriorization During Cesarean Section

Complications; Cesarean Section Clinical Trial

Official title:
Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01723605
Other study ID # 32012
Secondary ID
Status Completed
Phase Phase 3
First received November 4, 2012
Last updated December 28, 2013
Start date October 2012
Est. completion date December 2013

Study information
Verified date December 2013
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.

Description:

Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility Inclusion Criteria:

- pregnant women

Exclusion Criteria:

- liver disease

- kidney disease

- bleeding tendency

- abnormal placentation

- preeclampsia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• insitu repair
closure of the uterine incision while the uterus initu
• exteriorisation of the uterus
uterine closure while the uterus is exteriorised

Locations
Country Name City State
Egypt Faculty of medicine Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bowel movement Regain of bowel movement 12 hours Yes
Secondary Surgery duration The duration of intraoperative surgey 2 hours Yes
See also
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Completed NCT02587013 - Comparison of Uterine Repair Methods for Cesarean Delivery N/A
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