Using balloon occlusion to manage placenta accreta spectrum
Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial
This study tests if using balloon occlusion during cesarean sections can help women with placenta accreta spectrum have less bleeding and better outcomes while keeping their uterus intact.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06562712 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of using bilateral internal iliac artery balloon occlusion as a method to manage placenta accreta spectrum (PAS) during cesarean sections. PAS involves abnormal placental adhesion, and the study aims to reduce intraoperative blood loss and improve surgical outcomes while preserving the uterus and fertility. By temporarily blocking the main blood supply to the uterus, the procedure may enhance visibility and allow for better surgical planning. The study will compare this intervention to conventional management techniques.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 40 diagnosed with placenta accreta spectrum through ultrasound or MRI.
Not a fit: Patients with bleeding disorders, severe preoperative bleeding, or those requiring emergency cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for hysterectomy and improve surgical outcomes for women with placenta accreta spectrum.
How similar studies have performed: While the approach of using balloon occlusion is not widely tested, similar interventions have shown promise in managing surgical complications in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 40 years. * Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings. Exclusion Criteria: * Women with a bleeding disorder. * History of known allergy to contrast media. * Women with Impaired renal function. * Emergency cesarean section. * Women had severe attack of bleeding before the operation affecting patient's general condition. * Women had previous four or more cesarean scars. * If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed I Eleissawy, MD
- Email: mohamed.elesawy@med.tanta.edu.eg
- Phone: 00201110036328
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.