Conservative Management for PAS Pilot

Utah System of Higher Education (USHE)

Status: Enrolling

Conditions: Placenta Accreta

Treatments: Procedure: Conservative management for placenta accreta spectrum (PAS); Procedure: Cesarean hysterectomy for placenta accreta spectrum (PAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05139498

144922

Details and patient eligibility

About

Conservative in situ management is a promising alternative treatment to hysterectomy for patients with placenta accreta spectrum and may be safer and preferable for some patients. This study will assess feasibility of a future randomized clinical trial comparing these treatments and provide novel data to inform shared decision-making and cost-effective care for patients with this deadly pregnancy disorder.

Full description

Placenta accreta spectrum (PAS) is an extremely morbid and increasingly common pregnancy condition that often results in massive obstetric hemorrhage. The standard treatment in the United States is hysterectomy, but this treatment is complex, morbid, and costly. A promising alternative for PAS treatment is conservative in situ management (CM), a strategy in which the placenta is left in the uterus. Unfortunately, there are insufficient data available to compare outcomes of these two treatments because past studies are limited by non-randomized study designs, minimal inclusion of patient values in making treatment decisions, and nominal consideration of economic barriers to care. A large clinical trial comparing PAS treatments is needed. But there are key logistic barriers to an adequately powered trial, including questions of whether patients will enroll and adhere to randomization allocation. This pilot trial will evaluate the feasibility of randomizing patients to CM versus hysterectomy for PAS.

While pilot studies cannot make final assessments of safety and efficacy between interventions, safety and efficacy will be monitored, including those related to hemorrhage, transfusion, infection and re-operation.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and older
• History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
• Patients who would typically be recommended for hysterectomy
• Planned delivery between 34w0d and 36w0d gestation.

Exclusion criteria

• Plan to delivery before neonatal viability (<24 weeks gestation)
• Hospitalized for antenatal hemorrhage
• Have a low antenatal suspicion for PAS based on imaging
• Are pregnant with multiples (twins, triplets)
• Have a uterine fetal demise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Conservative Management for Placenta Accreta Spectrum (PAS)

Experimental group

Description:

Subjects who are randomized to to conservative management will undergo a cesarean delivery followed by a period of close observation in the operating room for 30-45 minutes to be sure there is no excessive bleeding or risk to keep the placenta inside

Treatment:

Procedure: Conservative management for placenta accreta spectrum (PAS)

Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS)

Active Comparator group

Description:

Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together

Treatment:

Procedure: Cesarean hysterectomy for placenta accreta spectrum (PAS)