Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

Not Applicable

Not yet recruiting

• Conditions: Placenta Accreta Spectrum
• Interventions: Other: Conservative/Expectant Management

• Registration Number: NCT06512181
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Study Start: 2024-11-01
• Primary Completion: 2030-09-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 15

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 16-36 weeks pregnant with an intrauterine gestation
5. History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
6. Patients for whom the usual management would be cesarean-hysterectomy.
7. Patient desires uterine preservation
8. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.

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Exclusion Criteria

• Have a low antenatal suspicion for PAS based on imaging.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uterine preservation	Conservative/Expectant Management	Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.

Primary Outcome Measures

Name	Time	Method
Hysterectomy rate	Delivery through 1 year	Percent of participants who undergo a hysterectomy

Secondary Outcome Measures

Name	Time	Method
Endometritis rate	Delivery through 1 year	Percent of participants who have endometritis
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
Coagulopathy rate	Delivery through 1 year	Percent of participants who have coagulopathy

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States