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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2023-10-24

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pregnant women

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

* ECG
* circulating sex hormones levels

Group Type OTHER

evaluation of QT interval duration

Intervention Type OTHER

ECG to evaluation of QT interval duration

circulating sex hormones levels sample

Intervention Type OTHER

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

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

Group Type OTHER

evaluation of QT interval duration

Intervention Type OTHER

ECG to evaluation of QT interval duration

circulating sex hormones levels sample

Intervention Type OTHER

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

Interventions

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evaluation of QT interval duration

ECG to evaluation of QT interval duration

Intervention Type OTHER

circulating sex hormones levels sample

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes