RecruitingNot ApplicableNCT06185894

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

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


Sponsor

Cairo University

Enrollment

40 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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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Interventions

PROCEDUREUterovesical 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

PROCEDUREConventional conservative surgery

Conventional conservative surgery


Locations(1)

Cairo University

Cairo, Egypt

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NCT06185894


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