Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

NCT06512181 | Recruiting

• 1 other identifier: 854957
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hysterectomy rate

  Percent of participants who undergo a hysterectomy

  Delivery through 1 year

Secondary Outcomes (4)

• Endometritis rate

  Delivery through 1 year

• Coagulopathy rate

  Delivery through 1 year

• Frequency of vaginal bleeding

  Delivery through 1 year

• Frequency of pelvic pain

  Delivery through 1 year

Study Arms (1)

Uterine preservation

EXPERIMENTAL

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

Other: Conservative/Expectant Management

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.

Uterine preservation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Beth Pineles, MD PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Pineles, MD Phd

CONTACT

267-226-7933; beth.pineles@pennmedicine.upenn.edu

Meaghan McCabe, MPH

CONTACT

meaghan.mccabe@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology,Assistant Professor of Obstetrics and Gynecology in Biostatistics and Epidemiology

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: April 21, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)