Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conservative/Expectant Management.
- Who it may be relevant to
- Registry conditions: Placenta Accreta Spectrum. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Other 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 measures
- Hysterectomy rate [Time frame: Delivery through 1 year]
Secondary outcome measures (4)
- Endometritis rate [Time frame: Delivery through 1 year]
- Coagulopathy rate [Time frame: Delivery through 1 year]
- Frequency of vaginal bleeding [Time frame: Delivery through 1 year]
- Frequency of pelvic pain [Time frame: Delivery through 1 year]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06512181 · 854957