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 — OTHER
    At 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 preservation
    Conservative 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

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Beth Pineles, MD PhD
267-226-7933

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