Skip to main content
OpenTrials
Completed

NCT Number: NCT02931695

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'investigation Clinique - Paris est

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

evaluation of QT interval duration

Other

ECG to evaluation of QT interval duration

circulating sex hormones levels sample

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

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

Registry information

Acronym: QuTe

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Oct 13, 2016
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.