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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: evaluation of QT interval duration; Other: circulating sex hormones levels sample

• Registration Number: NCT02931695
• Lead Sponsor: French Cardiology Society

Brief 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

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 Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Study Start: 2017-04-24
• Primary Completion: 2022-04-24
• Study Completion: 2023-10-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
women in the first trimester of post partum	circulating sex hormones levels sample	Women (same in first arm) in the first trimester of post partum * ECG * circulating sex hormones levels
women in the first trimester of post partum	evaluation of QT interval duration	Women (same in first arm) in the first trimester of post partum * ECG * circulating sex hormones levels
pregnant women	evaluation of QT interval duration	Women during third trimester of pregnancy and in the first trimester of post partum * ECG * circulating sex hormones levels
pregnant women	circulating sex hormones levels sample	Women during third trimester of pregnancy and in the first trimester of post partum * ECG * circulating sex hormones levels

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre d'investigation Clinique - Paris est; 🇫🇷 Paris, France