Conservative Management for PAS Pilot

NCT ID: NCT05139498

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2026-06-30

Brief Summary

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.

Detailed 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.

Conditions

Placenta Accreta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conservative Management for Placenta Accreta Spectrum (PAS)

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

Group Type: EXPERIMENTAL

Conservative management for placenta accreta spectrum (PAS)

Intervention Type: PROCEDURE

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

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

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

Group Type: ACTIVE_COMPARATOR

Cesarean hysterectomy for placenta accreta spectrum (PAS)

Intervention Type: PROCEDURE

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

Interventions

Conservative management for placenta accreta spectrum (PAS)

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

Intervention Type: PROCEDURE

Cesarean hysterectomy for placenta accreta spectrum (PAS)

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Brett Einerson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brett Einerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashley Joseph

Role: CONTACT

ashley.joseph@hsc.utah.edu

801-903-3278

Elizabeth Turner

Role: CONTACT

elizabeth.e.turner@hsc.utah.edu

801-213-2845

Facility Contacts

Elizabeth Turner

Role: primary

elizabeth.e.turner@hsc.utah.edu

801-213-2845

References

Griffith AM, Dalton SE, Kennedy AM, Woodward PJ, Einerson BD. Clinical and Radiologic Evolution in Conservative Management of Placenta Accreta Spectrum Disorder. Obstet Gynecol. 2025 Jun 1;145(6):739-748. doi: 10.1097/AOG.0000000000005931. Epub 2025 May 2.

Reference Type: DERIVED

PMID: 40373321 (View on PubMed)

Other Identifiers

144922

Identifier Type: -

Identifier Source: org_study_id