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

Placenta Accreta Spectrum Clinical Trial

Official title:

Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section：A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06383923
• Other study ID #: BYSYDL2022015
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Peking University Third Hospital
• Contact: Wang Yan, M.D.Ph.D.
• Phone: 13501282029
• Email: wjgqhn[@]263.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

• Pregnant women who did not terminate pregnancy at the Obstetrics Department of Peking University Third Hospital

• Pregnant women who gave birth at <28 weeks.

Related Conditions & MeSH terms

• Placenta Accreta
• Placenta Accreta Spectrum

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placenta Accreta Spectrum	Clinical diagnosis and classification standards are based on the diagnostic standards recommended by FIGO in 2019	2 years
Secondary	Amount of bleeding	Amount of bleeding in 24 hours after delivery	2 years
Secondary	Hemostatic measures	hemostatic measures after delivery	2 years
Secondary	hysterectomy	hysterectomy during the perinatal period	2 years
Secondary	blood transfusion volume	Postpartum blood transfusion volume	2 years