Bladder Flap Technique In Elective Cesarean Section

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03016273

Collaborator

(none)

150

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 20, 2017

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the skin - delivery time [duration of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assuit university	Asyut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasmin mohamed Alaa eldin mahmoud Youssef, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT03016273

Other Study ID Numbers:

BFCS

First Posted:

Jan 10, 2017

Last Update Posted:

Jul 5, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 5, 2017