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

Placenta Accreta Spectrum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752513
• Other study ID #: MS-345-2022
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: May 1, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: Abdalla Mousa, Lecturer
• Phone: 01277664430
• Email: Dr_abdallamousa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Intervention

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
• early bladder dissection
The bladder dissection is early as in classic cesarean hysterectomy

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of blood loss		during cesarean hysterectomy
Secondary	Operative time		during cesarean hysterectomy
Secondary	bladder injury		during cesarean hysterectomy
Secondary	ureteric injury		during cesarean hysterectomy
Secondary	Need for massive blood transfusion		during cesarean hysterectomy