Placenta Accreta SpectrumU-PRESERVENCT06512181
Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
A study testing Conservative/Expectant Management in people with Placenta Accreta Spectrum, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- Conservative/Expectant Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 31 Dec 2030
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- A person with a uterus, age 18 or older
- Currently pregnant with an intrauterine gestation or postpartum
- Suspected of having PAS based on history, clinical findings, and/or imaging
- Patients for whom the usual management would be peripartum hysterectomy.
- Patient desires uterine preservation or declines hysterectomy
- Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
Who cannot join
- Have a low antenatal suspicion for PAS based on imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meaghan McCabe, MPH contact
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Beth Pineles, MD PhD, 267-226-7933, beth.pineles@pennmedicine.upenn.edu
About this study
This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.
- Conditions
- Placenta Accreta Spectrum
- Being tested
- Conservative/Expectant Management
- 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/Expectant ManagementOther
At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.
| Study group | Role | What they receive |
|---|---|---|
| Uterine preservation | Experimental | Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring. Receives: Other: Conservative/Expectant Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hysterectomy rate
Percent of participants who undergo a hysterectomy
Measured: Delivery through 1 year
Secondary outcomes (4)
Endometritis rate
Percent of participants who have endometritis
Measured: Delivery through 1 year
Coagulopathy rate
Percent of participants who have coagulopathy
Measured: Delivery through 1 year
Frequency of vaginal bleeding
Percent of participants with vaginal bleeding at each time point
Measured: Delivery through 1 year
Frequency of pelvic pain
Percent of participants with pelvic pain at each time point
Measured: Delivery through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start21 Apr 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Pineles, University of Pennsylvania
- Investigators
- Beth Pineles, MD PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512181
- Sponsor's protocol ID
- 854957
- Acronym
- U-PRESERVE
- Status last verified
- May 2026
- First submitted
- 16 Jul 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared given the extremely small sample size and risk of participant identification
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06512181
- Acronym / sponsor ID
- U-PRESERVE / 854957
- Conditions
- Placenta Accreta Spectrum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jul 2024 (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.
This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uterine preservation | Experimental | Other: Conservative/Expectant ManagementConservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- A person with a uterus, age 18 or older
- Currently pregnant with an intrauterine gestation or postpartum
- Suspected of having PAS based on history, clinical findings, and/or imaging
Key exclusion criteria (1 listed)
- Have a low antenatal suspicion for PAS based on imaging.
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/Expectant ManagementAt time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus. | Other | Uterine preservation |
Primary outcome
Hysterectomy rate
Time frame: Delivery through 1 year
Percent of participants who undergo a hysterectomy
4 secondary outcomes
Endometritis rate
Time frame: Delivery through 1 year
Coagulopathy rate
Time frame: Delivery through 1 year
Frequency of vaginal bleeding
Time frame: Delivery through 1 year
Frequency of pelvic pain
Time frame: Delivery through 1 year
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 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared given the extremely small sample size and risk of participant identification
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Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
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Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
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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.
Meaghan McCabe, MPH contact
Beth Pineles, MD PhD principal investigator
University of Pennsylvania
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/Expectant Management in people with Placenta Accreta Spectrum, run by University of Pennsylvania 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 May 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?
Contact Beth Pineles, MD Phd (267-226-7933, beth.pineles@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hysterectomy rate (time frame: Delivery through 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.