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Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration

NCT02931695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-05

No results posted yet for this study

Summary

QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.

The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy

Conditions

  • Pregnancy

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

  • INSERM 1166 ICAN UPMC

    collaborator UNKNOWN

  • CIC1901-Centre d'Investigation Clinique Paris-Est

    collaborator UNKNOWN

  • French Cardiology Society

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2022-04-24
Completion
2023-10-24

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