Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

NCT ID: NCT06512181

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2030-12-31

Brief Summary

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.

Conditions

Placenta Accreta Spectrum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Uterine preservation

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

Group Type: EXPERIMENTAL

Conservative/Expectant Management

Intervention Type: OTHER

At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.

Interventions

Conservative/Expectant Management

At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Beth Pineles

Assistant Professor of Obstetrics and Gynecology,Assistant Professor of Obstetrics and Gynecology in Biostatistics and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beth Pineles, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Beth Pineles, MD Phd

Role: CONTACT

beth.pineles@pennmedicine.upenn.edu

267-226-7933

Meaghan McCabe, MPH

Role: CONTACT

meaghan.mccabe@pennmedicine.upenn.edu

Facility Contacts

Beth Pineles, MD PhD

Role: primary

beth.pineles@pennmedicine.upenn.edu

267-226-7933

Other Identifiers

854957

Identifier Type: -

Identifier Source: org_study_id