Using a uterine tourniquet during conservative management of placenta accreta to improve newborn APGAR
Impact of Using Tourniquet in Conservative Placenta Accrete Spectrum on Neonatal APGAR Score . A Randomized Controlled Trial .
This will try placing a tourniquet around the lower uterus during conservative management of placenta accreta in pregnant people (≥34 weeks, prior cesarean) to see if it improves newborn APGAR scores.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07412925 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls pregnant people with diagnosed placenta accreta spectrum (singleton pregnancies, age 20–40, gestation ≥34 weeks, prior cesarean) who are candidates for conservative management and elective delivery. At cesarean, a tourniquet is applied around the lower uterine segment as part of conservative placenta accreta management, with perioperative monitoring and standard obstetric care. The primary focus is on immediate neonatal APGAR scores and perioperative maternal outcomes related to bleeding and the need for additional procedures. The trial is conducted at Kasr Al Aini Hospitals, Faculty of Medicine, Cairo University.
Who should consider this trial
Good fit: Ideal candidates are pregnant people aged 20–40 with a singleton fetus at or beyond 34 weeks, prior cesarean delivery, diagnosed placenta accreta spectrum and planned elective conservative management with preoperative hemoglobin ≥10 g/dL.
Not a fit: People with significant medical or pregnancy-associated disorders, uterine pathology, premature rupture of membranes, multifetal pregnancies, cases misdiagnosed intraoperatively, or those requiring immediate hysterectomy are unlikely to benefit from this conservative tourniquet approach.
Why it matters
Potential benefit: If successful, the approach could reduce maternal bleeding during conservative management and improve newborn immediate condition as measured by APGAR scores.
How similar studies have performed: Small case series and surgical reports suggest uterine tourniquets or similar vascular control methods can reduce bleeding, but high-quality randomized evidence for this specific approach in placenta accreta is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 20-40 years old. 2. Pregnancy of a singleton living fetus. 3. Gestational age: pregnancy completing 34 weeks or more. 4. Previous one or more cesarean delivery. 5. Current pregnancy complicated by Placena Accreta Spectrum Disorder candidate for conservative managment either total or partial Placenta Accreta. 6. Elective termination of pregnancy. (35-37 weeks) 7. Preoperative Hemoglobin ≥ 10 g/dl. Exclusion Criteria: * 1-Patients who refuse to participate in the study. 2-Women with history of a concomitant chronic or a pregnancy associated medical disorder eg. Gestational diabetes, hypertension, cardiac or renal disease. 3-Presence of a concomitant uterine pathology (eg. Uterine fibroid) 4-Premature rupture of membranes. 5-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. 6-Cases requiring preoperative blood transfusion. 7- Any fetal abnormality e.g IUGR or SGA
Where this trial is running
Cairo
- kasr Al Aini Hospitals , Faculty of medicine , Cairo University , Cairo — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Yassmine A Hamouda, MSC
- Email: yassmineamrabdelmegid@hotmail.com
- Phone: 00201001680580
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.