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

NCT02931695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Long QT Syndrome

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).

Sponsors & Collaborators

  • Clinical Investigation Center Paris-Est (CIC-2503), AP-HP / INSERM

    collaborator UNKNOWN

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Joe-Elie SALEM, MD PHD · Centre d'investigation Clinique - Paris est

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2021-10-19
Completion
2026-02-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931695 on ClinicalTrials.gov