Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion

February 22, 2023 updated by: Abdalla Mousa, Cairo University

Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion

Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups

  • Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
  • Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age: reproductive age.
  2. Pregnant with singleton living fetus.
  3. Previous one or more cesarean sections.
  4. Gestational age: > 34 weeks.
  5. Elective or non-emergency cesarean sections.
  6. Preoperative hemoglobin more than 9.5 gm/dl.

Exclusion Criteria:

Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta
Procedure: early bladder dissection
The bladder dissection is early as in classic cesarean hysterectomy
Experimental: Group 2
18 pregnant women scheduled for bladder last cesarean hysterectomy
Procedure: Late bladder dissection
The bladder dissection is reserved as the last step of the cesarean hysterectomy with excellent dissection of the ureteric course till the ureteric tunnel to reduce the incidence of inadvertent ureteric clamping during uterine vessel ligating and transection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss
Time Frame: during cesarean hysterectomy
during cesarean hysterectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Operative time
Time Frame: during cesarean hysterectomy
during cesarean hysterectomy
bladder injury
Time Frame: during cesarean hysterectomy
during cesarean hysterectomy
ureteric injury
Time Frame: during cesarean hysterectomy
during cesarean hysterectomy
Need for massive blood transfusion
Time Frame: during cesarean hysterectomy
during cesarean hysterectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-345-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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