Ephedrine for Fetal Heart Tracing During Labor Analgesia

This study is investigating if a medication called Ephedrine can help prevent changes in a baby's heart rate during labor when a combined spinal and epidural (CSE) is used for pain relief. CSE can sometimes lead to a type of fetal heart rate tracing called Category II, which means the baby's heart rate might be abnormal. Researchers want to see if giving Ephedrine, which is not routinely used for this purpose, can reduce the chance of this happening. You may be eligible to participate if you are a woman between 18 and 55 years old, requesting labor pain relief, and your baby's heart tracing is normal before the CSE. The study will measure how many participants experience a Category II fetal heart rate tracing 30 minutes after receiving the pain medication.

Study design
This interventional study plans to enroll 100 participants. It will compare Ephedrine to a placebo (normal saline) to see its effect.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured 30 minutes after intrathecal opiate administration.

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NCT05873218

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE

Recruiting
PHASE4Ages 18–55InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~100 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:EphedrineNormal Saline Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of category II fetal heart rate tracing
Measured over day 1, 30 minutes after administration of intrathecal opiate
Labor
1 sites across 1 states
New York1
  • James Leader · STUDY_DIRECTOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

Refusal of neuraxial anesthesia
History of hypertension
Suspected pre-eclampsia
Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia
  • Incidence of category II fetal heart rate tracingday 1, 30 minutes after administration of intrathecal opiate

    Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate