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Bladder Flap Technique In Elective Cesarean Section

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.
 
ClinicalTrials.gov Identifier: NCT03016273
Recruitment Status : Unknown
Verified July 2017 by Yasmin mohamed Alaa eldin mahmoud Youssef, Assiut University.
Recruitment status was:  Recruiting
First Posted : January 10, 2017
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Yasmin mohamed Alaa eldin mahmoud Youssef, Assiut University

Brief Summary:
Cesarean section is a surgical procedure used to deliver one or more babies. cesarean section is usually performed when vaginal delivery will put the mother or child's health or life at risk. In recent years, the number of cesarean section has risen worldwide.

Condition or disease Intervention/treatment Phase
Cesarean Delivery Procedure: creation of bladder flap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Bladder Flap Versus Non Bladder Flap Technique In Women Undergoing Elective Cesarean Section A Randomized Controlled Trial
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Bladder flap
The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment.
Procedure: creation of bladder flap
Creation of the bladder flap, i.e., dissecting the urinary bladder from the lower segment of the uterus is a standard part of cesarean section (CS).

No Intervention: Non bladder flap



Primary Outcome Measures :
  1. the skin - delivery time [ Time Frame: duration of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective primary cesarean section
  2. previous cesarean section
  3. gestational age 32 or more.

Exclusion Criteria:

  1. Patients undergoing emergent cesarean section
  2. Patients undergoing planned vertical uterine incision.
  3. Patients undergone previous laparotomies.
  4. Gestational age less than 32 weeks .
  5. Patient refusing to participate in the study
  6. Women with body mass index >35

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): NCT03016273


Contacts
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Contact: Yasmin Youssef, MBBCh 00201068248305 yasminalaa92@gmail.com
Contact: Tarek A. Farghaly, PHD +20100 1338099 tarekabdelradi@yahoo.com

Locations
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Egypt
Assuit university Recruiting
Asyut, Egypt, 71515
Contact: Ahmed Abbas         
Sponsors and Collaborators
Assiut University
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Responsible Party: Yasmin mohamed Alaa eldin mahmoud Youssef, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03016273    
Other Study ID Numbers: BFCS
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No