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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05752513
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.2
• Patients Per Site Per Month: 16.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Placenta Accreta Spectrum; Cesarean Hysterectomy	Procedure: Late bladder dissection; Procedure: early bladder dissection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
• Actual Study Start Date: Feb 23, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Amount of blood loss [during cesarean hysterectomy]

Secondary Outcome Measures

1. Operative time [during cesarean hysterectomy]

2. bladder injury [during cesarean hysterectomy]

3. ureteric injury [during cesarean hysterectomy]

4. Need for massive blood transfusion [during cesarean hysterectomy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdalla Mousa, Lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05752513
• Other Study ID Numbers: MS-345-2022
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Placenta Accreta

Study Results

No Results Posted as of Mar 2, 2023