The Role of Using Tourniquet in Decreasing Bleeding in Placenta Accreta Spectrum Cases, a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Using Tourniquet in Decreasing Bleeding in Conservative Management of Placenta Accreta Spectrum Cases, a Randomized Controlled Trial

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Uterovesical tourniquet before uterine devascularization steps
* Procedure: Conventional conservative surgery


Participation Criteria
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Eligibility Criteria
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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 compeleted 34 weeks (or more) confirmed by the 1st day of the LMP or 1st trimesteric 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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: conservation without the use of a tourniquet<br>surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet | Procedure: Conventional conservative surgery<br>* Conventional conservative surgery<br>|
| Active Comparator: conservation with the use of a tourniquet<br>surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction | Procedure: Uterovesical tourniquet before uterine devascularization steps<br>* Insertion of a Foley catheter tourniquet through broad ligament apertures & tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum<br>* Other names: Uterine Pringles maneuver;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative quantified blood loss | Quantified blood loss estimate with the tourniquet | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of blood and blood product transfusion | amount of blood and blood product transfusion | during operation and 48 hours post operative |