Using a temporary tourniquet to reduce blood loss during cesarean hysterectomy for placenta accreta
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): A Prospective Randomized Controlled Clinical Trial
This study is testing if using a temporary tourniquet during cesarean hysterectomy can help reduce blood loss for women with placenta accreta.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05936645 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of a temporary sub-placental uterine tourniquet in minimizing intraoperative blood loss during retrograde cesarean hysterectomy for patients diagnosed with placenta accreta spectrum disorder. The study involves a thorough preoperative assessment, including medical history, clinical examination, laboratory tests, and detailed ultrasound imaging to evaluate the condition of the placenta. All surgeries will be performed by the same surgical team to maintain consistency in the approach and technique. Participants will be closely monitored throughout the procedure to assess the impact of the tourniquet on blood loss.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women at 35 weeks gestation or more, with a history of cesarean delivery and diagnosed with placenta accreta spectrum disorder.
Not a fit: Patients with chronic medical conditions, uterine pathologies, or those misdiagnosed with placenta accreta may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce intraoperative blood loss, improving safety and outcomes for patients undergoing cesarean hysterectomy due to placenta accreta.
How similar studies have performed: While the use of tourniquets in surgical procedures is not novel, the specific application in managing placenta accreta spectrum disorder through this method is relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Research Ethics Committee, Faculty of Medicine, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Eltawil, MSc
- Email: ahmed.eltawil512@gmail.com
- Phone: +201100009781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.