NCT06383923

Brief Summary

  1. 1.Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 25, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

April 15, 2024

Last Update Submit

April 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Placenta Accreta Spectrum

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

    2 years

Secondary Outcomes (4)

  • Amount of bleeding

    2 years

  • Hemostatic measures

    2 years

  • hysterectomy

    2 years

  • blood transfusion volume

    2 years

Study Arms (1)

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.

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

placenta and uterus

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Wang Yan, M.D.Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 25, 2024

Study Start

January 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 25, 2024

Record last verified: 2024-01

Locations