Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease

February 21, 2024 updated by: Chunyan Ma, First Hospital of China Medical University

Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial

The First Affiliated Hospital of China Medical University initiated a multi-center study to evaluate the changes of maternal fetal heart structure and function in pregnancies with cardiovascular disease by echocardiography, to explore the impact of cardiovascular disease on maternal fetal heart, so as to provide an important reference for obstetric pregnancy risk stratification and management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Globally, the incidence rate of pregnancy with cardiovascular disease is about 1-4%, and about 15% of maternal deaths are caused by pregnancy with cardiovascular disease related complications. With the opening of China's three children policy and the increase of older mothers, the proportion of maternal deaths caused by pregnancy combined with cardiovascular disease has increased year by year, which has become the primary cause of death of critically ill pregnancies in China. In addition, maternal cardiovascular disease is also the cause of fetal growth and development, cardiac structure abnormalities, and myocardial function damage. Therefore, early sensitive detection of changes in maternal and fetal cardiac structure and function during pregnancy, accurate risk assessment of pregnancy, detailed risk stratification, timely intervention and early evaluation of therapeutic efficacy can greatly reduce maternal mortality and ensure maternal and fetal safety.

Echocardiography is the preferred method for maternal fetal heart examination during pregnancy, because it is safe and convenient, and has no radiation risk to pregnancies and fetus. It can accurately and quickly measure and evaluate cardiac cavity size, hemodynamic changes and cardiac function, and can timely detect changes in the structure and function of pregnancies and fetuses at an early stage, and conduct continuous follow-up and close monitoring in different periods of pregnancy. In recent years, most of the domestic and foreign studies on the evaluation of echocardiography in pregnancy with cardiovascular disease are single center, small sample studies, mostly for a single disease, and the follow-up time is short. Some research results are contradictory and controversial, which can not accurately reflect the maternal fetal heart changes in pregnancy with cardiovascular disease. Therefore, it is urgent to conduct a large sample, multi-center study on the evaluation of cardiovascular disease in pregnancy by echocardiography in order to provide important reference and value for the stratification and management of pregnancy risk.

In conclusion, this study used echocardiography to evaluate the changes of maternal and fetal cardiac structure and function in pregnancies with cardiovascular disease, and to explore the impact of cardiovascular disease on maternal and fetal cardiac structure and function, so as to provide an important reference for obstetric pregnancy risk stratification and management, and help clinical monitoring and management of pregnancy with cardiovascular disease.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154002
        • Recruiting
        • Jiamusi Central Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The Third Affiliated Hospital of Zhengzhou University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Recruiting
        • Dalian Municipal Women and Children's Medical Center
        • Contact:
      • Jinzhou, Liaoning, China, 121000
        • Recruiting
        • Women And Children's Hospital of Jinzhou
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Weidong Ren, Ph.D
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang Maternity And Child Health Hospital
        • Contact:
        • Contact:
          • Jinmei Gao, MD
          • Phone Number: +86 13555858947
          • Email: gjmcy@163.com
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • the First Hospital of China Medical Univeristy
        • Contact:
        • Principal Investigator:
          • Chunyan Ma, MD
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • ShaanXi Province People's Hospital
        • Contact:
    • Shandong
      • Weifang, Shandong, China, 261011
        • Recruiting
        • Weifang Maternal and Child Health Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650051
        • Recruiting
        • Yunnan Maternal And Child Health Care Hospital
        • Contact:

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

A total of 200 pregnant women in the first trimester (gestational age of 6-13 weeks+6 days), who had cardiovascular disease and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 10 centers, with 20 cases in each center.

Description

Inclusion Criteria:

  • Pregnant women in the first trimester；
  • 20-45 years;
  • Complicated with cardiovascular diseases (mainly including congenital heart disease, aortic disease, valvular heart disease, coronary artery disease, cardiomyopathy, arrhythmia, hypertension, venous thromboembolism and other cardiovascular diseases).

Exclusion Criteria:

  • Other serious diseases of the immune, respiratory, digestive, nervous, urinary, blood, endocrine and other systems;
  • Tumors;
  • The poor quality of ultrasound images cannot meet the requirements of parameter measurement and analysis.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trial group
A total of 200 pregnant women in the first trimester (gestational age of 6-13 weeks+6 days), who had cardiovascular disease and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 10 centers, with 20 cases in each center.
Device: Echocardiography
Maternal and fetal echocardiography：Time points for heart image acquisition in pregnant women: As per the Guidelines for Pre-pregnancy and Pregnancy Health Care (2018) formulated by the Obstetrics Group of the Gynecology Branch of the Chinese Medical Association, a total of five echocardiographic examinations will be performed in the first trimester(11-14 weeks of gestation), the second trimester(20-24 weeks of gestation), the third trimester(29-32 weeks of gestation), prenatal term (37-40 weeks of gestation), and 3-6 months after delivery. Time points for fetal heart image acquisition: Fetal heart images will be collected in the second trimester(20 to 24 weeks of gestation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction
Time Frame: From 11 weeks of gestation to 3-6 months postpartum
To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
From 11 weeks of gestation to 3-6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular global longitudinal strain
Time Frame: From 11 weeks of gestation to 3-6 months postpartum
To Evaluate of the subclinical changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
From 11 weeks of gestation to 3-6 months postpartum

Collaborators and Investigators

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

Sponsor

First Hospital of China Medical University

Investigators

  • Principal Investigator: Chunyan Ma, MD, First Hospital of China Medical University

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 (Actual)

January 1, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF-CAD

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

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.

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