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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06383923
Other study ID # BYSYDL2022015
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Not yet recruiting NCT04525001 - MOGGE PAR Scores for Prediction of Outcomes of PAS
Completed NCT04427592 - New Conservative Technique for Placenta Accreta Spectrum N/A
Completed NCT04314791 - Accuracy of Placenta Accreta Index in Diagnosing Placenta Accreta Spectrum
Completed NCT06356493 - Prophylactic Occlusion Balloons of Both Internal Iliac Arteries in Caesarean Hysterectomy for PASD
Recruiting NCT05752513 - Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion N/A
Not yet recruiting NCT04229953 - Accuracy of Three /Four-dimensional Ultrasound in Diagnosing Placenta Accreta Spectrum
Completed NCT05500404 - Diagnostic Accuracy of Placental Thickness in Lower Uterine Segment Measured By Ultrasound in Prediction of Placenta Accreta Spectrum in Patients With Placenta Previa. A Diagnostic Test Accuracy Study
Recruiting NCT05510076 - Evaluation of Different Surgical Approaches Used for Conservative Management of Placenta Accreta Spectrum in Sohag University Hospital
Not yet recruiting NCT05481606 - Cesarean Scar Pregnancy and Clinical Outcomes
Recruiting NCT04866888 - Placenta Accreta Spectrum Outcome After Uterine Conservation N/A