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Active, Not Recruiting

NCT Number: NCT05139498

Conservative Management for PAS Pilot

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

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

    Time frame: Day of delivery

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

Secondary outcomes

  1. Number of eligible people approached for enrollment.

    Time frame: 20 weeks gestation through day of delivery

    Number of eligible people approached for enrollment.

  2. Number of eligible people randomized.

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

    Number of eligible people randomized.

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

    Time frame: Day of delivery

    Number of enrolled completing hysterectomy on day of delivery.

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

    Time frame: Day of delivery

    Number of enrolled completing conservative management on day of delivery.

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

    Time frame: Up to 6 weeks postpartum

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

  6. Number of enrolled who are lost to follow-up through study end (inverse of retention).

    Time frame: Up to 6 weeks postpartum

    Number of enrolled who are lost to follow-up through study end (inverse of retention).

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

    Time frame: Up to 6 weeks postpartum

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 1, 2021
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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