Placenta Accreta SpectrumNCT06383923
Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section
An observational study of Placenta Accreta Spectrum, run by Peking University Third Hospital at 1 site in China.
Trial summary
1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS). 2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease; 3. 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
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2024
- 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: This study will prospectively collect pregnant women without history of cesarean sections who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024. The prospective study will exclude those who did not terminate pregnancy or gave birth in our hospital and those who gave birth at <28 weeks.
Who may be able to join
- Pregnant women without prior cesarean section
- Pregnant women who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024
Who cannot join
- Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital
- Pregnant women who gave birth at <28 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Wang Yan, M.D.Ph.D., 13501282029, wjgqhn@263.net
About this study
Official title: Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section：A Prospective Cohort Study
- Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
- Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;
- Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease.
Read the detailed description
The placenta accreta spectrum (PAS) is defined as abnormal placental trophoblast adherence with a wide range of myometrial invasion. It is a serious pregnancy complication that can lead to severe postpartum hemorrhage, which may necessitate hysterectomy, and could ultimately lead to maternal death.Previous studies have shown that women with the highest risk of PAS disorders are those with a prior cesarean section (CS) who present in the second trimester of pregnancy with any degree of placenta previa or low-lying placenta.PAS patients without prior CS represent about one-third of the entire PAS population.The strategy to identify at-risk patients without a prior CS has yet to be defined. This may lead to under identification of PAS patients without prior CS and create a missed opportunity to plan the delivery and improve prognosis in these women. Established risk factors distinct from prior CS delivery include in vitro fertilization (IVF), intrauterine implants, endometritis, uterine artery embolization manual placental removal, uterine malformation, adenomyosis, submucosal fibroids, smoking, maternal weight, maternal age, parity, and multifetal pregnancy. Large clinical studies focusing on PAS disorders in women without prior CS are, indeed, scarce.This study aims to explore the risk factors and prognosis of PAS without a history of cesarean section and try to establish the prediction model.
- Conditions
- Placenta Accreta Spectrum
- 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 |
|---|---|---|
| pregnant women | pregnant women without prior cesarean section（CS） who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placenta Accreta Spectrum
Clinical diagnosis and classification standards are based on the diagnostic standards recommended by FIGO in 2019
Measured: 2 years
Secondary outcomes (4)
Amount of bleeding
Amount of bleeding in 24 hours after delivery
Measured: 2 years
Hemostatic measures
hemostatic measures after delivery
Measured: 2 years
hysterectomy
hysterectomy during the perinatal period
Measured: 2 years
blood transfusion volume
Postpartum blood transfusion volume
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383923
- Sponsor's protocol ID
- BYSYDL2022015
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section：A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06383923
- Acronym / sponsor ID
- BYSYDL2022015
- Conditions
- Placenta Accreta Spectrum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Apr 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.
- Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
- Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;
- Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease.
Detailed description
The placenta accreta spectrum (PAS) is defined as abnormal placental trophoblast adherence with a wide range of myometrial invasion. It is a serious pregnancy complication that can lead to severe postpartum hemorrhage, which may necessitate hysterectomy, and could ultimately lead to maternal death.Previous studies have shown that women with the highest risk of PAS disorders are those with a prior cesarean section (CS) who present in the second trimester of pregnancy with any degree of placenta previa or low-lying placenta.PAS patients without prior CS represent about one-third of the entire PAS population.The strategy to identify at-risk patients without a prior CS has yet to be defined. This may lead to under identification of PAS patients without prior CS and create a missed opportunity to plan the delivery and improve prognosis in these women. Established risk factors distinct from prior CS delivery include in vitro fertilization (IVF), intrauterine implants, endometritis, uterine artery embolization manual placental removal, uterine malformation, adenomyosis, submucosal fibroids, smoking, maternal weight, maternal age, parity, and multifetal pregnancy. Large clinical studies focusing on PAS disorders in women without prior CS are, indeed, scarce.This study aims to explore the risk factors and prognosis of PAS without a history of cesarean section and try to establish the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | –pregnant women without prior cesarean section（CS） who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will prospectively collect pregnant women without history of cesarean sections who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024. The prospective study will exclude those who did not terminate pregnancy or gave birth in our hospital and those who gave birth at <28 weeks.
Key inclusion criteria (2 listed)
- Pregnant women without prior cesarean section
- Pregnant women who had prenatal check-ups and gave birth at the Obstetrics Department of Peking University Third Hospital from January 1, 2023 to December 31, 2024
Key exclusion criteria (2 listed)
- Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital
- Pregnant women who gave birth at <28 weeks.
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
Placenta Accreta Spectrum
Time frame: 2 years
Clinical diagnosis and classification standards are based on the diagnostic standards recommended by FIGO in 2019
4 secondary outcomes
Amount of bleeding
Time frame: 2 years
Hemostatic measures
Time frame: 2 years
hysterectomy
Time frame: 2 years
blood transfusion volume
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta Spectrum, run by Peking University Third Hospital at 1 site in China.
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 25 Apr 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Yan, M.D.Ph.D. (13501282029, wjgqhn@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placenta Accreta Spectrum (time frame: 2 years). 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 25 Apr 2024.