Placenta Accreta Spectrum
Conditions
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.
Interventions
OTHERConservative/Expectant Management
At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hysterectomy rate | Delivery through 1 year | Percent of participants who undergo a hysterectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometritis rate | Delivery through 1 year | Percent of participants who have endometritis |
| Coagulopathy rate | Delivery through 1 year | Percent of participants who have coagulopathy |
| Frequency of vaginal bleeding | Delivery through 1 year | Percent of participants with vaginal bleeding at each time point |
| Frequency of pelvic pain | Delivery through 1 year | Percent of participants with pelvic pain at each time point |
Countries
United States
Contacts
CONTACTBeth Pineles, MD Phd
CONTACTMeaghan McCabe, MPH
PRINCIPAL_INVESTIGATORBeth Pineles, MD PhD
University of Pennsylvania
Outcome results
None listed