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

January 4, 2024 updated by: French Cardiology Society

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sex steroid hormones are known to influence heart repolarization. Overall, estradiol is considered to promote QTc lengthening while progesterone and testosterone shorten QTc. New findings suggest more complex regulation of QTc by sex steroid hormones involving also follicle-stimulating hormone, which is associated to prolongation of QTc. Another important aim of this study is to study the influence of sex hormones on QTc duration.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Centre d'investigation Clinique - Paris est

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult (>18 yo) pregnant women in their third trimester
  • Able to give her consent

Exclusion Criteria:

  • Concomitant intake of QTcF prolonging drugs
  • Past medical history of cardiovascular or endocrino-metabolic conditions (except hypertension or diabetes)
  • QRS >120 msec on electrocardiogram

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: pregnant women

Women during third trimester of pregnancy and in the first trimester of post partum

  • ECG
  • circulating sex hormones levels
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).
Other: women in the first trimester of post partum

Women (same in first arm) in the first trimester of post partum

  • ECG
  • circulating sex hormones levels
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in QTcF duration (Corrected for heart rate according to Fridericia method) between third trimester of pregnancy and post-partum.
Time Frame: third trimester of pregnancy and 3 to 6 months delivery
third trimester of pregnancy and 3 to 6 months delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).
Time Frame: third trimester of pregnancy and 3 to 6 months delivery
third trimester of pregnancy and 3 to 6 months delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

INSERM 1166 ICAN UPMC
CIC1901-Centre d'Investigation Clinique Paris-Est

Investigators

  • Principal Investigator: Joe-Elie SALEM, MD PHD, Centre d'investigation Clinique - Paris est

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2017

Primary Completion (Actual)

April 24, 2022

Study Completion (Actual)

October 24, 2023

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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