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RecruitingNCT06383923Updated Apr 25, 2024

Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section

An observational study in Placenta Accreta Spectrum, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Placenta Accreta Spectrum

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 200 is above the median of 87 across 78 observational studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital
  • Pregnant women who gave birth at \<28 weeks.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Placenta Accreta Spectrum

    Clinical diagnosis and classification standards are based on the diagnostic standards recommended by FIGO in 2019

    Time frame: 2 years

Secondary outcomes

  1. Amount of bleeding

    Amount of bleeding in 24 hours after delivery

    Time frame: 2 years

  2. Hemostatic measures

    hemostatic measures after delivery

    Time frame: 2 years

  3. hysterectomy

    hysterectomy during the perinatal period

    Time frame: 2 years

  4. blood transfusion volume

    Postpartum blood transfusion volume

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Dec 2024, 23 months after the start.

Of 34 observational studies under Placenta Accreta, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's planned 23 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2024
First posted
Apr 25, 2024
StartActual
Jan 1, 2023
Primary completionEst.
Dec 2024
CompletionEst.
Dec 2024
Last update
Apr 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06383923
Responsible party
Sponsor
First posted
Apr 25, 2024
Start date
Jan 1, 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 25, 2024

Study contacts

Wang Yan, M.D.Ph.D.
Contact
wjgqhn@263.net
13501282029

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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