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

Sponsor

French Cardiology Society (Other)

Overall Status

Completed

CT.gov ID

NCT02931695

Collaborator

INSERM 1166 ICAN UPMC (Other), CIC1901-Centre d'Investigation Clinique Paris-Est (Other)

Enrollment

Location

Arms

55.8

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Other: evaluation of QT interval duration Other: circulating sex hormones levels sample	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Apr 24, 2017

Actual Primary Completion Date :

Dec 17, 2021

Actual Study Completion Date :

Dec 17, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Other: pregnant women

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

ECG to evaluation of QT interval duration

Other: circulating sex hormones levels sample

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

Other: 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

Other: evaluation of QT interval duration

ECG to evaluation of QT interval duration

Other: circulating sex hormones levels sample

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'investigation Clinique - Paris est	Paris		France	75015

Sponsors and Collaborators

French Cardiology Society
INSERM 1166 ICAN UPMC
CIC1901-Centre d'Investigation Clinique Paris-Est

Investigators

Principal Investigator: Joe-Elie SALEM, MD PHD, Centre d'investigation Clinique - Paris est

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

French Cardiology Society

ClinicalTrials.gov Identifier:

NCT02931695

Other Study ID Numbers:

2016-01

First Posted:

Oct 13, 2016

Last Update Posted:

Apr 4, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by French Cardiology Society

post partum

Additional relevant MeSH terms:

Hormones

Study Results

No Results Posted as of Apr 4, 2022