Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
1 other identifier
interventional
60
1 country
1
Brief Summary
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
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
Study Start
First participant enrolled
March 31, 2018
CompletedFirst Submitted
Initial submission to the registry
August 26, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedSeptember 19, 2018
September 1, 2018
10 months
August 26, 2018
September 16, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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 icluding all cs over the period of one year
3 months post operative filling cystometry
3 months post operative
Study Arms (2)
bladder dissection before uterine incision
ACTIVE COMPARATORbladder dissection after uterine incision
EXPERIMENTALInterventions
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
Eligibility Criteria
You may qualify if:
- Women with BMI at or under 35 Kg/m2.
- Women having previous two cesarean section or more.
- Women with gestational age more than 32 weeks with viable fetus.
- Women with any degree of placenta previa .
- Patient with morbidly adherent placenta on cesarean scar only.
You may not qualify if:
- Patient who are haemodynamically unstable before skin incision.
- Patient with clinically evident intraamniotic infection.
- Patient with previous history of bladder injury .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Maternity Hospital
Cairo, 02, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of obs and gyn atainshams university
Study Record Dates
First Submitted
August 26, 2018
First Posted
September 19, 2018
Study Start
March 31, 2018
Primary Completion
February 1, 2019
Study Completion
March 31, 2019
Last Updated
September 19, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share