Recruiting

Ephedrine

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05873218

Conditions

Labor

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Ephedrine

Normal Saline Placebo

Study Details

Brief summary:

Labor analgesia is an important component of the care of laboring patients. A known side effect of combined spinal and epidural anesthesia (a type of labor analgesia) is an increased incidence of category II fetal heart rate tracing (defined below) and low blood pressure. The study team aims to study if a prophylactic dose of ephedrine will decrease the occurrence of this type of tracing after combined spinal epidural (CSE) anesthesia placement. Ephedrine is not currently routinely used as prevention for category II tracings or low blood pressure. The use of Ephedrine in this study is investigational (this is the first time that the drug has been studied for its effect on these conditions).

Fetal heart rate (FHR) tracings are classified into three categories. In clinical practice, FHR tracing categories are used as a guide to obstetric management and suggest the following approach:

  • Category I tracing is "reactive" and reassuring → may continue labor
  • Category II tracing is neither category I nor category III. For obvious reasons, category II is the broadest and largest category, consisting of various FHR tracing patterns that do not fit into either category I or category III.
  • Category III tracing is non-reassuring → expedited vaginal or cesarean delivery recommended.

A Category II tracing is not diagnostic. Most pregnancies have at least one Category II tracing. There is not always an identifiable reason for a Category II tracing.

Ephedrine is a medication that causes an increase in heart rate and blood pressure while also causing some degree of relaxation of the uterus therefore improving uterine blood flow. It has been used in the obstetric population for over 50 years without issues. The dose that the research team will administer, 7.5 mg, is below the dose the research team will often administer to treat hypotension (low blood pressure).

Conditions

Labor

Study ID

NCT05873218

Start date

Jun 26, 2023

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Ephedrine

3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 7.5 mg ephedrine IV will be administered to the patient, 12 minutes later, a second dose of 7.5mg will be administered to the patient as long as the patient is not hypertensive (BP no greater than 140/90)

placebo comparator: Placebo

3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 2.5cc 0.9% NS IV will be administered to the patient, 12 minutes later, a second dose of , 2.5cc 0.9% NS will be administered to the patient.

Interventions

Ephedrine

The intervention will be up to two 7.5 mg doses of ephedrine given after the placement of a combined spinal epidural with 25 mcg intrathecal fentanyl timed 3 and 15 minutes after intrathecal opiate administration.

Normal Saline Placebo

Placebo will be administered at matching rate.

Primary outcome measure

  • Incidence of category II fetal heart rate tracing [ Time Frame: day 1, 30 minutes after administration of intrathecal opiate ]

Central Contacts and Locations

Central contacts

Locations

Icahn School of Medicine at Mount SInai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Daniel Katz

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Randomized Control Trial
  • Prophylactic Ephedrine
  • Fetal Heart Rate Tracing
  • Combined Spinal Epidural
  • Labor analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-06.