Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery

Not Applicable

Recruiting

• Conditions: Placenta Accreta
• Interventions: Procedure: Conventional conservative surgery; Procedure: Uterovesical tourniquet before uterine devascularization steps

• Registration Number: NCT06185894
• Lead Sponsor: Cairo University

Brief Summary

Background: An optimal international standard for PAS surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in PAS management.

Objective: To assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum.

Patients and Methods: 40 pregnant women who underwent conservative management of placenta accrete at Kasr El-Aini hospital (Obstetrics and gynecology department - Faculty of medicine - Cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: Study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.Control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-01
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Pregnant females with previous CS deliveries (at least 1).
• Patients with ultrasound criteria of placenta accerta spectrum.
• Patients desiring fertility (uterine conservation).
• Patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimester ultrasound scan.

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Exclusion Criteria

• Maternal age above 40 years.
• Chronic medical disorders (e.g., cardiac, renal, DM and hepatic diseases).
• Patients presented with severe antepartum hemorrhage (unstable vital signs).
• Patients requested radical management (caesarean hysterectomy).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservation without the use of a tourniquet	Conventional conservative surgery	surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet
conservation with the use of a tourniquet	Uterovesical tourniquet before uterine devascularization steps	surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction

Primary Outcome Measures

Name	Time	Method
Intraoperative quantified blood loss	during operation	Quantified blood loss estimate with the tourniquet

Secondary Outcome Measures

Name	Time	Method
amount of blood and blood product transfusion	during operation and 48 hours post operative	amount of blood and blood product transfusion

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt