Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT06512181
- Status
- Recruiting
Conditions
- Placenta Accreta Spectrum
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Conservative/Expectant Management — OTHERAt time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.
Study Details
This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.
Key Dates
- Start date
- Apr 21, 2025
- Status verified
- May 2026
- Primary completion
- Sep 1, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Uterine preservationConservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.
Primary Outcome Measure
Hysterectomy rate [ Time Frame: Delivery through 1 year ]
Central Contacts
- Beth Pineles, MD Phd267-226-7933
- Meaghan McCabe, MPH
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 |