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NCT Number: NCT06512181

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

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.

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Key information

Conditions

Placenta Accreta Spectrum Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Accreta Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Beth Pineles, MD PhD

CONTACT

[email protected]

267-226-7933

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Conservative/Expectant Management

Other

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

Primary outcomes

  1. Hysterectomy rate

    Time frame: Delivery through 1 year

    Percent of participants who undergo a hysterectomy

Secondary outcomes

  1. Endometritis rate

    Time frame: Delivery through 1 year

    Percent of participants who have endometritis

  2. Coagulopathy rate

    Time frame: Delivery through 1 year

    Percent of participants who have coagulopathy

  3. Frequency of vaginal bleeding

    Time frame: Delivery through 1 year

    Percent of participants with vaginal bleeding at each time point

  4. Frequency of pelvic pain

    Time frame: Delivery through 1 year

    Percent of participants with pelvic pain at each time point

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Pineles, MD Phd

CONTACT

[email protected]

267-226-7933

Meaghan McCabe, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: U-PRESERVE

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 22, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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