Bladder Flap Technique In Elective Cesarean Section

Bladder Flap Versus Non Bladder Flap Technique In Women Undergoing Elective Cesarean Section A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Delivery
• Intervention / Treatment: Procedure: creation of bladder flap

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Recruiting
    • Assuit university
    • Contact: Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the skin - delivery time	duration of surgery

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BFCS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No