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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06185894
Other study ID # Ms-105-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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