Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Placenta Accreta Spectrum
- Sponsor
- University of Pennsylvania
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Hysterectomy rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Beth Pineles
Assistant Professor of Obstetrics and Gynecology,Assistant Professor of Obstetrics and Gynecology in Biostatistics and Epidemiology
University of Pennsylvania
Eligibility Criteria
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 16-36 weeks pregnant with an intrauterine gestation
- •History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
- •Patients for whom the usual management would be cesarean-hysterectomy.
- •Patient desires uterine preservation
- •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.
Outcomes
Primary Outcomes
Hysterectomy rate
Time Frame: Delivery through 1 year
Percent of participants who undergo a hysterectomy
Secondary Outcomes
- Endometritis rate(Delivery through 1 year)
- Frequency of vaginal bleeding(Delivery through 1 year)
- Frequency of pelvic pain(Delivery through 1 year)
- Coagulopathy rate(Delivery through 1 year)