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

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.

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta Spectrum
• Intervention / Treatment: Other: Conservative/Expectant Management

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meaghan McCabe, MPH; Email: meaghan.mccabe@pennmedicine.upenn.edu
• Study Contact Backup: Name: Beth Pineles, MD PhD; Phone Number: 267-226-7933; Email: beth.pineles@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Beth Pineles, MD PhD; Phone Number: 267-226-7933; Email: beth.pineles@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 pregnant with an intrauterine gestation or postpartum
5. Suspected of having PAS based on history, clinical findings, and/or imaging
6. Patients for whom the usual management would be peripartum hysterectomy.
7. Patient desires uterine preservation or declines hysterectomy
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Uterine preservation; Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.	Other: Conservative/Expectant Management; At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hysterectomy rate	Percent of participants who undergo a hysterectomy	Delivery through 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometritis rate	Percent of participants who have endometritis	Delivery through 1 year
Coagulopathy rate	Percent of participants who have coagulopathy	Delivery through 1 year
Frequency of vaginal bleeding	Percent of participants with vaginal bleeding at each time point	Delivery through 1 year
Frequency of pelvic pain	Percent of participants with pelvic pain at each time point	Delivery through 1 year

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Beth Pineles, MD PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: 854957

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared given the extremely small sample size and risk of participant identification

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No