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

French Cardiology Society

Status: Completed

Conditions: Pregnancy

Treatments: Other: circulating sex hormones levels sample; Other: evaluation of QT interval duration

Study type: Interventional

Funder types: Other

Identifiers

NCT02931695

2016-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 2 patient groups

pregnant women

Other group

Description:

Women during third trimester of pregnancy and in the first trimester of post partum * ECG * circulating sex hormones levels

Treatment:

Other: circulating sex hormones levels sample

Other: evaluation of QT interval duration

women in the first trimester of post partum

Other group

Description:

Women (same in first arm) in the first trimester of post partum * ECG * circulating sex hormones levels

Treatment:

Other: circulating sex hormones levels sample

Other: evaluation of QT interval duration