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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Uterovesical tourniquet before uterine devascularization steps

    Procedure/Surgery

    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

    Procedure/Surgery

    Conventional conservative surgery

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: conservation without the use of a tourniquetPlacebo comparator 1 intervention
Group B: conservation with the use of a tourniquetActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative quantified blood loss

Quantified blood loss estimate with the tourniquet

Time frame
during operation

Secondary outcomes

1

amount of blood and blood product transfusion

amount of blood and blood product transfusion

Time frame
during operation and 48 hours post operative

Other outcomes

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