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Can hormones during pregnancy reshape the Heart's electrical beat?

NCT ID NCT02931695

Knowledge-focused Sponsor: French Cardiology Society Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study tracks heart rhythm changes in women from late pregnancy to after delivery, comparing healthy women and those with congenital long QT syndrome, a condition that affects the heart's electrical activity. Researchers use ECGs and blood tests to measure how sex hormones like progesterone and estradiol relate to the heart's repolarization—the recovery phase between beats. The goal is to understand how pregnancy-related hormonal shifts might influence heart rhythm risk, potentially improving care for at-risk mothers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ECG monitoring and blood hormone level measurements
What this could lead to
Could improve how doctors measure heart rhythm risk in pregnant women, especially those with long QT syndrome, potentially guiding safer monitoring.
What could go wrong
This is an observational study, so it won't test a treatment. Results may not apply to all women, and hormone-heart rhythm links could be complex.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

90 people

The number who actually took part.

Started

Apr 2017

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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. Exclusion Criteria: * Uninterpretable ventricular repolarization. * Hormonal or QT-modifying treatment still active at V2. * Cardiovascular complication that occurred after V1 and was still ongoing at V2.

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Conditions

The condition(s) this trial relates to.

familial long QT syndrome long QT syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Long QT syndrome Pregnancy

Contacts and locations

Locations

  • Clinical Investigation Center Paris-Est, Pitié-Salpêtrière University Hospital

    Paris, 75013, France

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