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NCT02931695 Clinical Trial

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

Pregnancy Clinical Trial

— QuTe  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02931695
Other study ID # 2016-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2017
Est. completion date October 24, 2023

Study information
Verified date January 2024
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date October 24, 2023
Est. primary completion date April 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• evaluation of QT interval duration
ECG to evaluation of QT interval duration
• circulating sex hormones levels sample
Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).

Locations
Country Name City State
France Centre d'investigation Clinique - Paris est Paris

Sponsors (3)
Lead Sponsor Collaborator
French Cardiology Society CIC1901-Centre d'Investigation Clinique Paris-Est, INSERM 1166 ICAN UPMC

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in QTcF duration (Corrected for heart rate according to Fridericia method) between third trimester of pregnancy and post-partum. third trimester of pregnancy and 3 to 6 months delivery
Secondary Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis). third trimester of pregnancy and 3 to 6 months delivery
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