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

NCT ID: NCT06185894

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Placenta Accreta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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conservation without the use of a tourniquet

surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, without the use of a tourniquet

Group Type PLACEBO_COMPARATOR

Conventional conservative surgery

Intervention Type PROCEDURE

Conventional conservative surgery

conservation with the use of a tourniquet

surgical conservation of placenta accreta spectrum cases with Kasr alainy conservative management technique, with the use of a uterovesical tourniquet before fetal extraction

Group Type ACTIVE_COMPARATOR

Uterovesical tourniquet before uterine devascularization steps

Intervention Type PROCEDURE

Insertion of a Foley catheter tourniquet through broad ligament apertures \& tightening it immediately before hysterotomy in cases of conservative management of placenta accreta spectrum

Interventions

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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

Intervention Type PROCEDURE

Conventional conservative surgery

Conventional conservative surgery

Intervention Type PROCEDURE

Other Intervention Names

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Uterine Pringles maneuver

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 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdalla Mousa

Lecturer of obgyn Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Abdalla Mousa

Role: primary

+201277664430

Other Identifiers

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Ms-105-2023

Identifier Type: -

Identifier Source: org_study_id

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