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Active, not recruitingNCT05139498Updated Apr 15, 2026

Conservative Management for PAS Pilot

An interventional study of Conservative management for placenta accreta spectrum (PAS) and Cesarean hysterectomy for placenta accreta spectrum (PAS) in Placenta Accreta, sponsored by University of Utah. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Placenta Accreta

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Keywords

  • Pregnancy
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In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's enrollment of 4 is below the median of 70 across 67 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • ProcedureConservative 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

  • ProcedureCesarean 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

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What researchers measure

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.

    Time frame: Day of delivery

Secondary outcomes

  1. Number of eligible people approached for enrollment.

    Number of eligible people approached for enrollment.

    Time frame: 20 weeks gestation through day of delivery

  2. Number of eligible people randomized.

    Number of eligible people randomized.

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

  3. Number of enrolled completing hysterectomy on day of delivery.

    Number of enrolled completing hysterectomy on day of delivery.

    Time frame: Day of delivery

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

    Number of enrolled completing conservative management on day of delivery.

    Time frame: Day of delivery

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

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

    Time frame: Up to 6 weeks postpartum

  6. 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).

    Time frame: Up to 6 weeks postpartum

  7. Number of enrolled completing full postpartum follow-up visit schedule.

    Number of enrolled completing full postpartum follow-up visit schedule.

    Time frame: Up to 6 weeks postpartum

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Study locations

1 site
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References and documents

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. PubMed 40373321 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05139498
Lead sponsor
University of Utah
Responsible party
Brett Einerson (Principal Investigator, University of Utah) — Principal investigator
First posted
Dec 1, 2021
Start date
May 26, 2022
Primary completion
Jan 26, 2026
Completion
Jun 30, 2027 (estimated)
Last update
Apr 15, 2026

Study contacts

Brett Einerson, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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