Conservative Management for PAS Pilot

  • STATUS
    Recruiting
  • End date
    May 14, 2025
  • participants needed
    32
  • sponsor
    University of Utah
Updated on 14 June 2022

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.

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.

Details
Condition Placenta Accreta
Treatment Conservative management for placenta accreta spectrum (PAS), Cesarean hysterectomy for placenta accreta spectrum (PAS)
Clinical Study IdentifierNCT05139498
SponsorUniversity of Utah
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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