Conservative Management for PAS Pilot

NCT05139498 | Active Not Recruiting DMC

• 1 other identifier: 144922
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of patients completing the surgical treatment to which they are allocated

  Number of patients completing the surgical treatment to which they are allocated (hysterectomy or conservative management) on the day of delivery.

  Day of delivery

Secondary Outcomes (7)

• Number of eligible people approached for enrollment.

  20 weeks gestation through day of delivery

• Number of eligible people randomized.

  From time of consent up to one week (1-7 days) before planned delivery

• Number of enrolled completing hysterectomy on day of delivery.

  Day of delivery

• Number of enrolled completing conservative management on day of delivery.

  Day of delivery

• Number of enrolled who don't complete their allocated treatment (drop-out).

  Up to 6 weeks postpartum

Study Arms (2)

Conservative Management for Placenta Accreta Spectrum (PAS)

EXPERIMENTAL

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

Procedure: Conservative management for placenta accreta spectrum (PAS)

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

ACTIVE COMPARATOR

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

Procedure: Cesarean hysterectomy for placenta accreta spectrum (PAS)

Interventions

Cesarean hysterectomy for placenta accreta spectrum (PAS) PROCEDURE

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

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

Conservative management for placenta accreta spectrum (PAS) 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

Conservative Management for Placenta Accreta Spectrum (PAS)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• 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.

  PMID: 40373321 DERIVED

MeSH Terms

Conditions

Placenta Accreta

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Brett Einerson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 1, 2021
• Study Start: May 26, 2022
• Primary Completion: January 26, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)