Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

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.

Conditions

Placenta Accreta Spectrum

Study Overview

Study Details

Study overview

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.

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

Condition
Placenta Accreta Spectrum
Intervention / Treatment

-

Contacts and Locations

Philadelphia

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Beth Pineles, MD PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2030-12-31