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| Name | Class |
|---|---|
| INSERM 1166 ICAN UPMC | UNKNOWN |
| CIC1901-Centre d'Investigation Clinique Paris-Est | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant women | Other | Women during third trimester of pregnancy and in the first trimester of post partum
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| women in the first trimester of post partum | Other | Women (same in first arm) in the first trimester of post partum
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| evaluation of QT interval duration | Other | ECG to evaluation of QT interval duration |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe-Elie SALEM, MD PHD | Centre d'investigation Clinique - Paris est | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'investigation Clinique - Paris est | Paris | 75015 | France |
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| circulating sex hormones levels sample | Other | Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis). |
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