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Simple drug may prevent worrisome fetal heart tracings after epidural

NCT ID NCT05873218

Symptom relief Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a low dose of ephedrine right after an epidural can prevent abnormal fetal heart rate patterns in laboring women. About 100 women requesting labor pain relief will receive either ephedrine or a placebo. The goal is to see if ephedrine reduces the chance of a category II fetal heart tracing, which can be a sign of distress.

What this could mean

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

Active substance
Ephedrine
What this could lead to
If it works, this could give doctors a simple way to reduce the chance of fetal heart rate changes after epidural, making labor safer and less stressful.
What could go wrong
This is a small, early-phase study with only 100 participants, so results may not apply to all women. Ephedrine can raise blood pressure and heart rate, though the dose used is low and considered safe in obstetrics.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

May 2027

An estimate. End dates often move.

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 to 55 years

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: * Women aged 18-55 years * Requesting labor analgesia * Able to provide informed written consent * Category 1 fetal tracing prior to placement of neuraxial anesthesia Exclusion Criteria: * Refusal of neuraxial anesthesia * History of hypertension * Suspected pre-eclampsia * Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia

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As listed by the trial registrant

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

LABOR

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount SInai

    RECRUITING

    New York, New York, 10029, United States

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