Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta

Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy

Study Overview

• Status: Unknown
• Conditions: Morbidly Adherent Placenta
• Intervention / Treatment: Procedure: bladder dissection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hassan helmy, master; Phone Number: 01023308711; Email: saberaleek2222@yahoo.com
• Study Contact Backup: Name: mohamed elsenity, MD; Phone Number: 01226573332

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Recruiting
    • Ain shams university maternity hospital
    • Principal Investigator: mohamed elsenity, MD
    • Contact: Amr Elshalakany, Prof
    • Sub-Investigator: hassan helmy, master
    • Sub-Investigator: Amr EL-Shalakany, prof
    • Sub-Investigator: tamer borg, prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women with BMI at or under 35 Kg/m2.
2. Women having previous two cesarean section or more.
3. Women with gestational age more than 32 weeks with viable fetus.
4. Women with any degree of placenta previa .
5. Patient with morbidly adherent placenta on cesarean scar only.

Exclusion Criteria:

1. Patient who are haemodynamically unstable before skin incision.
2. Patient with clinically evident intraamniotic infection.
3. Patient with previous history of bladder injury .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bladder dissection before uterine incision	Procedure: bladder dissection; Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
Experimental: bladder dissection after uterine incision	Procedure: bladder dissection; Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	of whole cs	icluding all cs over the period of one year
Blood loss	through counting soaked towels and weighting them before and after being soaked considering the difference in grams as the calculated blood loss and calculating blood in the suction reservoir and comparing pre and post operative Hb level also haemotacrit level and number of units of packed RBCs transfused	icluding all cs over the period of one year
- Incidence of urological	- Incidence of urological injuries discovered intraoperative and procedure needed to repair or as a late complication as fistula formation.	during cs and post operative delayed complication icluding all cs over the period of one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal APGAR score	Neonatal APGAR score	after delivery of the baby during the 1st 15 minutes
Time taken to create bladder flap	from the start of bladder dissection	from the start of bladder dissection icluding all cs over the period of one year
3 months post operative filling cystometry	3 months post operative filling cystometry	3 months post operative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): March 31, 2019

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FWA000017585MD361/2017

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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