NCT06185894

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

December 15, 2023

Last Update Submit

June 1, 2024

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

  • Intraoperative quantified blood loss

    Quantified blood loss estimate with the tourniquet

    during operation

Secondary Outcomes (1)

  • amount of blood and blood product transfusion

    during operation and 48 hours post operative

Study Arms (2)

conservation without the use of a tourniquet

PLACEBO COMPARATOR

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

Procedure: Conventional conservative surgery

conservation with the use of a tourniquet

ACTIVE COMPARATOR

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

Interventions

Uterovesical tourniquet before uterine devascularization stepsPROCEDURE

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

Also known as: Uterine Pringles maneuver
conservation with the use of a tourniquet
Conventional conservative surgeryPROCEDURE

Conventional conservative surgery

conservation without the use of a tourniquet

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Mousa A, Gaafar HM, Abdullah M, Elsherbini MM, Abdel-Rasheed M, Rida D, Saysaneh A, Collins SL, Abdelbar A. Uterovesical tourniquet for conservative management of placenta accreta spectrum: a prospective cohort study in a low-resource setting. BMC Pregnancy Childbirth. 2025 Dec 12. doi: 10.1186/s12884-025-08381-7. Online ahead of print.

    PMID: 41387818DERIVED

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obgyn Cairo university

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 29, 2023

Study Start

October 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Locations

EG(1)