Accuracy of Risk Prediction Scores in Pregnant Women

Completed

• Conditions: Congenital Heart Disease; Pregnancy
• Interventions: Other: Retrospective observational

• Registration Number: NCT04221048
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-12-30
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PREG-GUCH	Retrospective observational	Pregnant women with congenital heart diseases

Primary Outcome Measures

Name	Time	Method
Number of Cardiovascular complications	From the 20th week of gestation until 6 months post partum	Cardiovascular complications during pregnancy until 6 months post partum

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France