Placenta Accreta Clinical Trial
— SPARTACUSOfficial title:
Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery (SPARTACUS) Study
Verified date | June 2024 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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 |
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