Conservative Management for PAS Pilot

Conservative Management as an Alternative to Hysterectomy for Placenta Accreta Spectrum: a Pilot Randomized Controlled Trial.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Conservative management for placenta accreta spectrum (PAS); Procedure: Cesarean hysterectomy for placenta accreta spectrum (PAS)

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of eligible people approached for enrollment.	Number of eligible people approached for enrollment.	20 weeks gestation through day of delivery
Number of eligible people randomized.	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.	Number of enrolled completing hysterectomy on day of delivery.	Day of delivery
Number of enrolled completing conservative management on 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).	Number of enrolled who don't complete their allocated treatment (drop-out).	Up to 6 weeks postpartum
Number of enrolled who are lost to follow-up through study end (inverse of retention).	Number of enrolled who are lost to follow-up through study end (inverse of retention).	Up to 6 weeks postpartum
Number of enrolled completing full postpartum follow-up visit schedule.	Number of enrolled completing full postpartum follow-up visit schedule.	Up to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Brett Einerson, MD, University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): January 26, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Placenta Diseases; Placenta Accreta; Therapeutics; Conservative Treatment
• Other Study ID Numbers: 144922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No