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Search / Trial NCT05936645

The Efficacy of a Temporary Sub-Placental Uterine Tourniquet in Minimizing Intraoperative Blood Loss in Management of Placenta Accreta Spectrum Disorder by a Retrograde Cesarean Hysterectomy (Bladder Last)

Launched by CAIRO UNIVERSITY · Jun 29, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Placenta Accreta Spectrum Tourniquet Cesarean Hysterectomy Bladder Last Blood Loss

ClinConnect Summary

This clinical trial is investigating whether using a temporary device, called a tourniquet, around the uterus can help reduce blood loss during surgery for women with a condition known as Placenta Accreta Spectrum Disorder. This condition occurs when the placenta attaches too deeply into the uterine wall, making it difficult to remove. The trial is open to women who are at least 35 weeks pregnant, have had previous cesarean deliveries, and need to undergo surgery to remove the uterus due to this complication.

If you or someone you know is considering participating, it's important to be aware of eligibility criteria. Participants must be pregnant and have a hemoglobin level of at least 10 g/dl, but they should not have any other serious medical conditions or complications. Those who join the trial will be monitored closely during the surgery to see if the tourniquet effectively helps minimize blood loss. This research aims to improve surgical outcomes for women facing this challenging condition.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Gestational age: pregnancy completing 35 weeks or more.
  • Previous one or more cesarean delivery.
  • Current pregnancy complicated by Placenta Accreta Spectrum Disorder candidate for cesarean hysterectomy either total or partial Placenta Accreta. (i.e. Total: Most of the placenta is adherent to the myometrium with no plane of cleavage. Partial: 2-3 cotyledons are only adherent to the myometrium with no plane of cleavage at these cotyledons)
  • Elective termination of pregnancy.
  • Preoperative Hemoglobin ≥ 10 g/dl
  • Exclusion Criteria:
  • Patients who refuse to participate in the study.
  • Women with history of a concomitant chronic or a pregnancy associated medical disorder eg. Gestational diabetes, hypertension, cardiac or renal disease.
  • Presence of a concomitant uterine pathology (eg. Uterine fibroid)
  • Premature rupture of membranes.
  • Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative or as total/partial accreta and found to be focal accreta intraoperative.
  • Cases requiring preoperative blood transfusion.

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, , Egypt

Patients applied

0 patients applied

Trial Officials

Moutaz M Elsherbini, MD

Study Director

Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported