PregnancyQuTeNCT02931695
Ventricular Repolarization During the Pregnancy-to-Postpartum Transition (QuTe)
An observational study of Pregnancy and Long QT Syndrome, run by French Cardiology Society at 1 site in France.
Trial summary
Pregnancy and the postpartum period are accompanied by marked changes in heart rate, circulating hormones, and electrolyte balance that may influence ventricular repolarization. This prospective longitudinal study evaluated adult women during the third trimester of pregnancy and again after delivery, including healthy… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Long QT Syndrome
- What is being tested?
- Evaluation of QT interval duration and Circulating sex hormones levels sample
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2017to 3 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of women recruited in collaboration with the Department of Obstetrics and Gynecology. Eligible participants were prospectively included in the study and underwent the clinical investigations planned as part of the research at the Clinical Investigation Center (CIC) Paris Est, Pitié-Salpêtrière Hospital.
Who may be able to join
- Female participant aged 18 years or older.
- Pregnant at the third-trimester inclusion visit (protocol window: 30-38 weeks of gestation).
- Affiliated with the French social security system.
- Able to understand French and provide written informed consent.
- Healthy pregnant women and pregnant women with congenital long QT syndrome were eligible.
Who cannot join
- Treatment known to modify QT duration, except beta-blockers clinically indicated antiarrhythmic treatment for congenital long QT syndrome.
- History of cardiac disease, except hypertension or congenital long QT syndrome (whether treated or untreated).
- History of endocrine disease, except non-insulin-requiring diabetes.
- Bundle branch block or QRS duration greater than 120 milliseconds.
- Post-Inclusion Exclusion Criteria:
- Ventricular repolarization not interpretable on the ECG.
Show all 11Show fewer
- Hormonal treatment or QT-modifying treatment initiated after inclusion and still active at the postpartum visit.
- Cardiovascular complication occurring after inclusion and still active at the postpartum visit.
- Uninterpretable ventricular repolarization.
- Hormonal or QT-modifying treatment still active at V2.
- Cardiovascular complication that occurred after V1 and was still ongoing at V2.
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center Paris-Est, Pitié-Salpêtrière University Hospital
Paris, 75013
About this study
Official title: Ventricular Repolarization During the Pregnancy-to-Postpartum Transition: A Longitudinal Comparison of QT Correction Methods and Hormonal Correlates
Pregnancy and the postpartum period are accompanied by marked changes in heart rate, circulating hormones, and electrolyte balance that may influence ventricular repolarization. This prospective longitudinal study evaluated adult women during the third trimester of pregnancy and again after delivery, including healthy participants and a prespecified subgroup with congenital long QT syndrome (cLQTS). Standardized triplicate 12-lead electrocardiograms and concomitant blood samples were obtained at both visits. The prespecified primary objective was to quantify the within-participant change in the Fridericia-corrected QT interval (QTcF) from late pregnancy to postpartum. Secondary objectives were to examine associations between QTcF and circulating sex hormones. Additional exploratory analyses compared Bazett and Fridericia heart-rate correction methods and evaluated longitudinal and visit-specific associations between QTcF and biochemical and endocrine biomarkers.
Read the detailed description
This single-center prospective longitudinal cohort enrolled pregnant adult women during the third trimester, including healthy participants and women with cLQTS. Participants underwent a third-trimester visit (V1) and a postpartum follow-up visit (V2). No therapeutic intervention was assigned by the study.
At each visit, three consecutive 10-second standard 12-lead electrocardiograms were recorded under standardized resting conditions. QT measurements were obtained using a semi-automated computer-assisted triplicate concatenation method with expert review of fiducial points. QT was corrected for heart rate using both Bazett (QTcB) and Fridericia (QTcF) formulas. The ECG outcome assessment was performed without knowledge of whether the recording was obtained during pregnancy or postpartum.
Blood sampling was performed concomitantly with ECG acquisition. The biochemical and endocrine assessment included routine electrolytes and a broad panel of reproductive, thyroid, pituitary, placental, and adrenal biomarkers, including an LC-MS/MS steroid profile.
The prespecified primary endpoint was the within-participant change in QTcF between V1 and V2. Prespecified secondary analyses evaluated associations between QTcF and progesterone, estradiol, testosterone, and follicle-stimulating hormone, including associations between within-participant hormone changes and QTcF changes. Exploratory analyses evaluated residual heart-rate dependence of QTcB and QTcF and screened an expanded biomarker panel using longitudinal and physiological-state-specific models.
- Conditions
- Pregnancy, Long QT Syndrome
- Being tested
- Evaluation of QT interval duration, Circulating sex hormones levels sample
- Keywords
- Postpartum period, ventricular repolarization, QT interval, QTcF, Fridericia correction, QTcB, Bazett correction, sex hormones, cLQTS, calcium, potassium, SHBG
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of QT interval durationOther
ECG to evaluation of QT interval duration
Circulating sex hormones levels sampleOther
Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Adult pregnant women without cLQTS. Seventy-eight were enrolled; two were excluded at the first visit, leaving 76 eligible for analysis; 62 completed the postpartum assessment. Receives: Other: Evaluation of QT interval duration; Other: Circulating sex hormones levels sample | |
| Pregnant women with cLQTS | Adult pregnant women with congenital long QT syndrome. Twelve were enrolled and included at the first visit; 10 completed the postpartum assessment. Clinically indicated antiarrhythmic/beta-blocker therapy was permitted. Receives: Other: Evaluation of QT interval duration; Other: Circulating sex hormones levels sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fridericia-Corrected QT Interval (QTcF) From Late Pregnancy to Postpartum
Within-participant postpartum minus third-trimester QTcF, in milliseconds, measured from standardized triplicate 12-lead ECGs using a semi-automated computer-assisted method with expert review.
Measured: Third-trimester visit and postpartum follow-up visit. Planned window: 30-38 weeks' gestation and 2 weeks-12 months after delivery.
Secondary outcomes (2)
Association Between Circulating Sex Hormone Concentrations and QTcF
Univariable and multivariable associations of progesterone, estradiol, testosterone, and follicle-stimulating hormone concentrations with QTcF at the pregnancy and postpartum visits.
Measured: Third-trimester visit and postpartum follow-up visit.
Association Between Within-Participant Changes in Sex Hormones and Change in QTcF
Association between pregnancy-to-postpartum changes in progesterone, estradiol, testosterone, and follicle-stimulating hormone concentrations and the within-participant change in QTcF.
Measured: From the third-trimester visit to the postpartum follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start24 Apr 2017
- Primary completion19 Oct 2021
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Center Paris-Est (CIC-2503), AP-HP / INSERM
- Responsible party
- Sponsor
- Investigators
- Joe-Elie SALEM, MD PHD, Principal investigator, Centre d'investigation Clinique - Paris est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931695
- Sponsor's protocol ID
- 2016-01
- Acronym
- QuTe
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2016
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventricular Repolarization During the Pregnancy-to-Postpartum Transition: A Longitudinal Comparison of QT Correction Methods and Hormonal Correlates
- ClinicalTrials.gov ID
- NCT02931695
- Acronym / sponsor ID
- QuTe / 2016-01
- Conditions
- Pregnancy, Long QT Syndrome
- Keywords
- Postpartum period, ventricular repolarization, QT interval, QTcF, Fridericia correction, QTcB, Bazett correction, sex hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Clinical Investigation Center Paris-Est (CIC-2503), AP-HP / INSERM
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnancy and the postpartum period are accompanied by marked changes in heart rate, circulating hormones, and electrolyte balance that may influence ventricular repolarization. This prospective longitudinal study evaluated adult women during the third trimester of pregnancy and again after delivery, including healthy participants and a prespecified subgroup with congenital long QT syndrome (cLQTS). Standardized triplicate 12-lead electrocardiograms and concomitant blood samples were obtained at both visits. The prespecified primary objective was to quantify the within-participant change in the Fridericia-corrected QT interval (QTcF) from late pregnancy to postpartum. Secondary objectives were to examine associations between QTcF and circulating sex hormones. Additional exploratory analyses compared Bazett and Fridericia heart-rate correction methods and evaluated longitudinal and visit-specific associations between QTcF and biochemical and endocrine biomarkers.
Detailed description
This single-center prospective longitudinal cohort enrolled pregnant adult women during the third trimester, including healthy participants and women with cLQTS. Participants underwent a third-trimester visit (V1) and a postpartum follow-up visit (V2). No therapeutic intervention was assigned by the study.
At each visit, three consecutive 10-second standard 12-lead electrocardiograms were recorded under standardized resting conditions. QT measurements were obtained using a semi-automated computer-assisted triplicate concatenation method with expert review of fiducial points. QT was corrected for heart rate using both Bazett (QTcB) and Fridericia (QTcF) formulas. The ECG outcome assessment was performed without knowledge of whether the recording was obtained during pregnancy or postpartum.
Blood sampling was performed concomitantly with ECG acquisition. The biochemical and endocrine assessment included routine electrolytes and a broad panel of reproductive, thyroid, pituitary, placental, and adrenal biomarkers, including an LC-MS/MS steroid profile.
The prespecified primary endpoint was the within-participant change in QTcF between V1 and V2. Prespecified secondary analyses evaluated associations between QTcF and progesterone, estradiol, testosterone, and follicle-stimulating hormone, including associations between within-participant hormone changes and QTcF changes. Exploratory analyses evaluated residual heart-rate dependence of QTcB and QTcF and screened an expanded biomarker panel using longitudinal and physiological-state-specific models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | – | Other: Evaluation of QT interval duration, Other: Circulating sex hormones levels sampleAdult pregnant women without cLQTS. Seventy-eight were enrolled; two were excluded at the first visit, leaving 76 eligible for analysis; 62 completed the postpartum assessment. |
| Pregnant women with cLQTS | – | Other: Evaluation of QT interval duration, Other: Circulating sex hormones levels sampleAdult pregnant women with congenital long QT syndrome. Twelve were enrolled and included at the first visit; 10 completed the postpartum assessment. Clinically indicated antiarrhythmic/beta-blocker therapy was permitted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of women recruited in collaboration with the Department of Obstetrics and Gynecology. Eligible participants were prospectively included in the study and underwent the clinical investigations planned as part of the research at the Clinical Investigation Center (CIC) Paris Est, Pitié-Salpêtrière Hospital.
Key inclusion criteria (5 listed)
- Female participant aged 18 years or older.
- Pregnant at the third-trimester inclusion visit (protocol window: 30-38 weeks of gestation).
- Affiliated with the French social security system.
- Able to understand French and provide written informed consent.
- Healthy pregnant women and pregnant women with congenital long QT syndrome were eligible.
Key exclusion criteria (11 listed)
- Treatment known to modify QT duration, except beta-blockers clinically indicated antiarrhythmic treatment for congenital long QT syndrome.
- History of cardiac disease, except hypertension or congenital long QT syndrome (whether treated or untreated).
- History of endocrine disease, except non-insulin-requiring diabetes.
- Bundle branch block or QRS duration greater than 120 milliseconds.
- Ventricular repolarization not interpretable on the ECG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of QT interval durationECG to evaluation of QT interval duration | Other | Healthy pregnant women, Pregnant women with cLQTS |
| Circulating sex hormones levels sampleAssociation between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis). | Other | Healthy pregnant women, Pregnant women with cLQTS |
Primary outcome
Change in Fridericia-Corrected QT Interval (QTcF) From Late Pregnancy to Postpartum
Time frame: Third-trimester visit and postpartum follow-up visit. Planned window: 30-38 weeks' gestation and 2 weeks-12 months after delivery.
Within-participant postpartum minus third-trimester QTcF, in milliseconds, measured from standardized triplicate 12-lead ECGs using a semi-automated computer-assisted method with expert review.
2 secondary outcomes
Association Between Circulating Sex Hormone Concentrations and QTcF
Time frame: Third-trimester visit and postpartum follow-up visit.
Association Between Within-Participant Changes in Sex Hormones and Change in QTcF
Time frame: From the third-trimester visit to the postpartum follow-up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe-Elie SALEM, MD PHD principal investigator
Centre d'investigation Clinique - Paris est
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Long QT Syndrome, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fridericia-Corrected QT Interval (QTcF) From Late Pregnancy to Postpartum (time frame: Third-trimester visit and postpartum follow-up visit. Planned window: 30-38 weeks' gestation and 2 weeks-12 months after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.