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Epidural drugs may affect Baby's heartbeat, study finds

NCT ID NCT01686347

Knowledge-focused Sponsor: University Hospital, Rouen 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether pain-relief drugs given during labor (ropivacaine and sufentanil) can pass into the mother's blood and cause abnormal heart rhythms in the baby. It involved 40 first-time mothers with a single baby in head-first position. The goal was to measure drug levels in the mother's blood and compare them to any fetal heart rate changes. The study was terminated early, so findings are preliminary.

What this could mean

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

Active substance
ropivacaine and sufentanil
What this could lead to
If successful, this could help doctors understand why some babies have heart rate changes after epidurals, leading to safer pain relief during labor.
What could go wrong
The study was terminated early with only 40 participants, so results are limited. It only looks at a possible link, not a proven cause, and may not apply to all pregnancies.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

40 people

The number who actually took part.

Start date

Jun 2012

Finished

Dec 2015

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.

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: * 18 years old or more * nulliparous \_ one fetus * head first * spontaneous labor * epidural analgesia * no fetal cardiac rhythm abnormalies before the epidural analgesia * no active management of labor during 30 minutes after the epidural analgesia induction * at term * signature of the consent form Exclusion Criteria: * pathological pregnancy * low maternal blood pressure during the 30 minutes after the epidural analgesia * uterin contraction which last for 5 minutes or more * more than 6 uterin contractions during a 10 minutes period * Ropivacaine contraindication * sufentanil contraindication

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease

As listed by the trial registrant

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

Fetal cardiac rhythm abnormalities

Contacts and locations

Locations

  • centre hospitalier universitaire de Rouen, Hopital Charles Nicolle

    Rouen, 76000, France