RECRUITING

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

Quick Facts

Study Start:2025-04-21
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06512181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form.
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. A person with a uterus, age 18 or older
  4. 4. Currently 16-36 weeks pregnant with an intrauterine gestation
  5. 5. History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
  6. 6. Patients for whom the usual management would be cesarean-hysterectomy.
  7. 7. Patient desires uterine preservation
  8. 8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Beth Pineles, MD Phd
CONTACT
267-226-7933
beth.pineles@pennmedicine.upenn.edu
Meaghan McCabe, MPH
CONTACT
meaghan.mccabe@pennmedicine.upenn.edu

Principal Investigator

Beth Pineles, MD PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Beth Pineles, MD PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-21
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-04-21
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Placenta Accreta Spectrum