NCT02931695

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

April 24, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

5 years

First QC Date

September 15, 2016

Last Update Submit

January 4, 2024

Conditions

Pregnancy

Keywords

post partum

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

pregnant women

OTHER

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

Other: evaluation of QT interval durationOther: circulating sex hormones levels sample

women in the first trimester of post partum

OTHER

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

Other: evaluation of QT interval durationOther: circulating sex hormones levels sample

Interventions

evaluation of QT interval durationOTHER

ECG to evaluation of QT interval duration

pregnant womenwomen in the first trimester of post partum
circulating sex hormones levels sampleOTHER

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

pregnant womenwomen in the first trimester of post partum

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (\>18 yo) pregnant women in their third trimester
  • Able to give her consent

You may not qualify if:

  • Concomitant intake of QTcF prolonging drugs
  • Past medical history of cardiovascular or endocrino-metabolic conditions (except hypertension or diabetes)
  • QRS \>120 msec on electrocardiogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation Clinique - Paris est

Paris, 75015, France

Location

Study Officials

  • Joe-Elie SALEM, MD PHD

    Centre d'investigation Clinique - Paris est

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

October 13, 2016

Study Start

April 24, 2017

Primary Completion

April 24, 2022

Study Completion

October 24, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

FR(1)