Prospective Cohort Observational Study of Placenta Accreta Spectrum Disorders

August 27, 2023 updated by: Dunjin Chen, Guangzhou Medical University
The incidence of placenta accreta spectrum disorders has shown an increasing trend worldwide due to the increase of cesarean section rate. Research on the outcomes of placenta accreta spectrum disorders primarily relies on retrospective analysis. The aim of this study was to establish a prospective, multicenter cohort in China in order to conduct further investigations on the clinical features, predictive capabilities, diagnostic methods, and pathogenesis of placenta accreta spectrum disorders.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 510150
        • Department of Obstetrics and Gynecology, Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology，The Third Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Pregnant women aged 18-45 who at least had one previous cesarean section

Description

Inclusion Criteria:

  1. Pregnant women aged 18-45;
  2. at least one previous cesarean section ,regular antenatal examination and plan to give birth at research center
  3. sign informed consent

Exclusion Criteria:

Irregular antenatal examination; Twins; Autoimmune diseases; Prepregnancy hypertension; Prepregnancy diabetes mellitus; Inheritance Sexual diseases; tumor; Abnormal liver and kidney function in early pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of placenta accreta spectrum disorders
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Preterm delivery Preterm delivery
Time Frame: baseline
baseline
Blood lost during delivery
Time Frame: baseline
baseline
Blood loss in the first 24 hours of delivery
Time Frame: baseline
baseline
hysterectomy
Time Frame: baseline
baseline
Blood transfusion
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Collaborators

Peking University First Hospital
Peking Union Medical College Hospital
Peking University Third Hospital
First Affiliated Hospital of Chongqing Medical University
Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University
TONGJI MEDICAL COLLEGE OF HUST
West China Second University Hospital,Sichuan University / West China women's and children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 28, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 7, 2025

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022YFC2704501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Placenta Accreta Spectrum Disorders,Previous Cesarean Section

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