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

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: evaluation of QT interval duration
* Other: circulating sex hormones levels sample


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pregnant women<br>Women during third trimester of pregnancy and in the first trimester of post partum ECG circulating sex hormones levels | Other: evaluation of QT interval duration<br>* ECG to evaluation of QT interval duration<br>Other: circulating sex hormones levels sample<br>* Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).<br>|
| Other: women in the first trimester of post partum<br>Women (same in first arm) in the first trimester of post partum ECG circulating sex hormones levels | Other: evaluation of QT interval duration<br>* ECG to evaluation of QT interval duration<br>Other: circulating sex hormones levels sample<br>* Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post partum