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

Placenta Accreta Clinical Trial

— SPARTACUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185894
• Other study ID #: Ms-105-2023
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• Uterovesical tourniquet before uterine devascularization steps
Insertion of a Foley catheter tourniquet through broad ligament apertures & tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum
• Conventional conservative surgery
Conventional conservative surgery

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	Intraoperative quantified blood loss	Quantified blood loss estimate with the tourniquet	during operation
Secondary	amount of blood and blood product transfusion	amount of blood and blood product transfusion	during operation and 48 hours post operative