Placenta AccretaNCT05139498
Conservative Management for PAS Pilot
A study testing Conservative management for placenta accreta spectrum (PAS) and Cesarean hysterectomy for placenta accreta spectrum (PAS) in people with Placenta Accreta, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Conservative management for placenta accreta spectrum (PAS) and Cesarean hysterectomy for placenta accreta spectrum (PAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Placenta Accreta
- Being tested
- Conservative management for placenta accreta spectrum (PAS), Cesarean hysterectomy for placenta accreta spectrum (PAS)
- Keywords
- Pregnancy
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative management for placenta accreta spectrum (PAS)Procedure or surgery
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 or surgery
Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Cesarean hysterectomy for placenta accreta spectrum (PAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of delivery
Secondary outcomes (7)
Number of eligible people approached for enrollment.
Number of eligible people approached for enrollment.
Measured: 20 weeks gestation through day of delivery
Number of eligible people randomized.
Number of eligible people randomized.
Measured: 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.
Measured: Day of delivery
Number of enrolled completing conservative management on day of delivery.
Number of enrolled completing conservative management on day of delivery.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start26 May 2022
- Primary completion26 Jan 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Einerson, University of Utah
- Investigators
- Brett Einerson, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139498
- Sponsor's protocol ID
- 144922
- Status last verified
- Feb 2026
- First submitted
- 13 Oct 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Management as an Alternative to Hysterectomy for Placenta Accreta Spectrum: a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05139498
- Acronym / sponsor ID
- 144922
- Conditions
- Placenta Accreta
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 26 May 2022 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Management for Placenta Accreta Spectrum (PAS) | Experimental | 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 |
| Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS) | Active comparator | 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Conservative Management for Placenta Accreta Spectrum (PAS) |
| 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 | Procedure or surgery | Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS) |
Primary outcome
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.
7 secondary outcomes
Number of eligible people approached for enrollment.
Time frame: 20 weeks gestation through day of delivery
Number of eligible people randomized.
Time frame: From time of consent up to one week (1-7 days) before planned delivery
Number of enrolled completing hysterectomy on day of delivery.
Time frame: Day of delivery
Number of enrolled completing conservative management on day of delivery.
Time frame: Day of delivery
Number of enrolled who don't complete their allocated treatment (drop-out).
Time frame: Up to 6 weeks postpartum
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 completing full postpartum follow-up visit schedule.
Time frame: Up to 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 40373321Griffith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Einerson, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative management for placenta accreta spectrum (PAS) and Cesarean hysterectomy for placenta accreta spectrum (PAS) in people with Placenta Accreta, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients completing the surgical treatment to which they are allocated (time frame: Day of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.