Managing placenta accreta spectrum while preserving the uterus
Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
This study is testing a new way to manage placenta accreta spectrum disorders by allowing some women to keep their uterus after delivery instead of having surgery, to see if it can be a safer option for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06512181 on ClinicalTrials.gov |
What this trial studies
This study focuses on the conservative management of placenta accreta spectrum disorders, which pose significant risks to maternal health. Instead of the common approach of cesarean-hysterectomy, this pilot study offers selected participants the option to leave the placenta in the uterus after delivery. The study will involve 15 participants who desire uterine preservation and will be monitored during their postpartum stay and through outpatient follow-up until the uterus is empty. This approach aims to provide a safer alternative for women facing this condition.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older, between 16-36 weeks gestation, with a history of cesarean delivery and suspected placenta accreta spectrum.
Not a fit: Patients with low antenatal suspicion for placenta accreta spectrum based on imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce maternal morbidity and mortality associated with placenta accreta spectrum disorders.
How similar studies have performed: While conservative management approaches have been explored, this specific pilot study represents a novel approach to managing placenta accreta spectrum disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Beth Pineles, MD PhD — University of Pennsylvania
- Study coordinator: Beth Pineles, MD Phd
- Email: beth.pineles@pennmedicine.upenn.edu
- Phone: 267-226-7933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.