Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders (U-PRESERVE)

University of Pennsylvania

Status: Enrolling

Conditions: Placenta Accreta Spectrum

Treatments: Other: Conservative/Expectant Management

Study type: Interventional

Funder types: Other

Identifiers

NCT06512181

854957

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. A person with a uterus, age 18 or older
4. Currently 16-36 weeks pregnant with an intrauterine gestation
5. History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
6. Patients for whom the usual management would be cesarean-hysterectomy.
7. Patient desires uterine preservation
8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

Exclusion criteria

• Have a low antenatal suspicion for PAS based on imaging.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Uterine preservation

Experimental group

Description:

Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.

Treatment:

Other: Conservative/Expectant Management