NCT03016273

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

January 9, 2017

Last Update Submit

July 3, 2017

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

  • the skin - delivery time

    duration of surgery

Study Arms (2)

Bladder flap

EXPERIMENTAL

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

Non bladder flap

NO INTERVENTION

Interventions

creation of bladder flapPROCEDURE

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).

Bladder flap

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

Yasmin Youssef, MBBCh

CONTACT

00201068248305yasminalaa92@gmail.com

Tarek A. Farghaly, PHD

CONTACT

+20100 1338099tarekabdelradi@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 10, 2017

Study Start

February 20, 2017

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

July 5, 2017

Record last verified: 2017-07

Locations

EG(1)