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

Morbidly Adherent Placenta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676855
• Other study ID #: FWA000017585MD361/2017
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2018
• Source: Ain Shams University
• Contact: hassan helmy, master
• Phone: 01023308711
• Email: saberaleek2222[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Morbidly Adherent Placenta

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	of whole cs	icluding all cs over the period of one year
Primary	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
Primary	- 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	Neonatal APGAR score	Neonatal APGAR score	after delivery of the baby during the 1st 15 minutes
Secondary	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
Secondary	3 months post operative filling cystometry	3 months post operative filling cystometry	3 months post operative