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Completed

NCT Number: NCT04221048

Accuracy of Risk Prediction Scores in Pregnant Women

Management of pregnancy and risk stratification in congenital heart disease (CHD) population might be challenging especially due to physiological haemodynamic modifications that inevitably occur during pregnancy. We aim to compare the accuracy of the main published scores including CARPREG II score in prediction of maternal complications during pregnancy in CHD patients.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this study

Since the end of the 20th century, surgical and medical care progresses have significantly improved prognosis and quality of life of patients with congenital heart diseases (CHD). Currently, women with CHD expect to experience a "normal" life and express a strong maternity desire.

During the last decade, several scores have been used to predict outcome of pregnancy in women with cardiovascular heart diseases. It has been suggested that the mWHO classification was more appropriate than the previous ones (e.g. Harris, Zahara and CAPREG classifications) in predicting cardiac complications in CHD. More recently, a new risk score stratification (CARPREG II) have been published to improve maternal risk stratification.

This retrospective study will include all pregnant women with CHD who were follow up in our institution from January 2007 to June 2018 until 6 months postpartum. The investigators will collect demographic and clinical data, type and complexity of CHD (Houyel and Bethesda classification), and pregnancy outcomes. Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes. The discriminatory power of each risk scores was assessed by the area-under-the receiver-operating characteristic (ROC) curve (AUC). In order to assess the reproducibility of scores classification assigned to CHD patients, all pregnancy scores from this cohort were assessed by 3 independent observers and, thereafter, estimated Cronbach's coefficient alpha.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with congenital heart diseases who deliver in our institution during the study period

Exclusion criteria

  • Women with acquired cardiovascular diseases

Treatment and study plan

Retrospective observational

Other

Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes

Primary outcomes

  1. Number of Cardiovascular complications

    Time frame: From the 20th week of gestation until 6 months post partum

    Cardiovascular complications during pregnancy until 6 months post partum

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Accuracy of Risk Prediction Scores in Pregnant Women With Congenital Heart Disease.

Acronym: PREG-GUCH

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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