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

Cairo University (CU)

Status: Enrolling

Conditions: Placenta Accreta

Treatments: Procedure: Uterovesical tourniquet before uterine devascularization steps; Procedure: Conventional conservative surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06185894

Ms-105-2023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

conservation without the use of a tourniquet

Placebo Comparator group

Description:

surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet

Treatment:

Procedure: Conventional conservative surgery

conservation with the use of a tourniquet

Active Comparator group

Description:

surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction

Treatment:

Procedure: Uterovesical tourniquet before uterine devascularization steps