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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06185894
Acronym
SPARTACUS
Enrollment
40
Registered
2023-12-29
Start date
2023-10-01
Completion date
2024-06-30
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

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.

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative quantified blood lossduring operationQuantified blood loss estimate with the tourniquet

Secondary

MeasureTime frameDescription
amount of blood and blood product transfusionduring operation and 48 hours post operativeamount of blood and blood product transfusion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026