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COMPLETED
NCT02931695

Ventricular Repolarization During the Pregnancy-to-Postpartum Transition (QuTe)

Sponsor: French Cardiology Society

View on ClinicalTrials.gov

Summary

Pregnancy and the postpartum period are accompanied by marked changes in heart rate, circulating hormones, and electrolyte balance that may influence ventricular repolarization. This prospective longitudinal study evaluated adult women during the third trimester of pregnancy and again after delivery, including healthy participants and a prespecified subgroup with congenital long QT syndrome (cLQTS). Standardized triplicate 12-lead electrocardiograms and concomitant blood samples were obtained at both visits. The prespecified primary objective was to quantify the within-participant change in the Fridericia-corrected QT interval (QTcF) from late pregnancy to postpartum. Secondary objectives were to examine associations between QTcF and circulating sex hormones. Additional exploratory analyses compared Bazett and Fridericia heart-rate correction methods and evaluated longitudinal and visit-specific associations between QTcF and biochemical and endocrine biomarkers.

Official title: Ventricular Repolarization During the Pregnancy-to-Postpartum Transition: A Longitudinal Comparison of QT Correction Methods and Hormonal Correlates

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

90

Start Date

2017-04-24

Completion Date

2026-02-03

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

OTHER

Evaluation of QT interval duration

ECG to evaluation of QT interval duration

OTHER

Circulating sex hormones levels sample

Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).

Locations (1)

Clinical Investigation Center Paris-Est, Pitié-Salpêtrière University Hospital

Paris, France