Placenta Accreta SpectrumNCT06477497
The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders
An observational study of Placenta Accreta Spectrum, run by Peking Union Medical College Hospital.
Trial summary
Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta Spectrum
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women with placenta accreta spectrum disorders
Who may be able to join
- Pregnant women who have regular prenatal examination at the research hospitals
- Pregnant women diagnosed with PAS before or after delivery
Who cannot join
- Pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy
- Pregnant women who were lost to follow-up during the study period
Trial locations and contacts
No sites are listed yet.
About this study
Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery.
To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.
- Conditions
- Placenta Accreta Spectrum
- Keywords
- placenta accreta spectrum disorders
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Theoretical training, technical supporting and standardized referral process | |
| control group | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
antepartum diagnosis rate of PAS
Measured: through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (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 Peking Union Medical College HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477497
- Sponsor's protocol ID
- 2022YFC2704505
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06477497
- Acronym / sponsor ID
- 2022YFC2704505
- Conditions
- Placenta Accreta Spectrum
- Keywords
- placenta accreta spectrum disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 27 Jun 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.
Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery.
To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Theoretical training, technical supporting and standardized referral process |
| control group | – | –usual care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with placenta accreta spectrum disorders
Key inclusion criteria (2 listed)
- Pregnant women who have regular prenatal examination at the research hospitals
- Pregnant women diagnosed with PAS before or after delivery
Key exclusion criteria (2 listed)
- Pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy
- Pregnant women who were lost to follow-up during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antepartum diagnosis rate of PAS
Time frame: through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta Spectrum, run by Peking Union Medical College Hospital.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinsong Gao (0861069156225, gaojingsong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antepartum diagnosis rate of PAS (time frame: through study completion, an average of 1.5 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 27 Jun 2024.