Recruiting

Conservative Management

Sponsor:

University of Pennsylvania

Code:

NCT06512181

Conditions

Placenta Accreta Spectrum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Conservative/Expectant Management

Study Details

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

Study ID

NCT06512181

Start date

Apr 21, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Uterine preservation

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

Interventions

Conservative/Expectant Management

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

Primary outcome measure

  • Hysterectomy rate [ Time Frame: Delivery through 1 year ]

Central Contacts and Locations

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

University of Pennsylvania

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-05-11.