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

NCT05873218 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY-22-01334
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of category II fetal heart rate tracing

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

  day 1, 30 minutes after administration of intrathecal opiate

Secondary Outcomes (10)

• Incidence of uterine tetanic contractions

  day 1, 30 minutes after administration of intrathecal opiate

• Incidence of uterine hypertorus

  day 1, 30 minutes after administration of intrathecal opiate

• Incidence of fetal bradycardia

  day 1, 30 minutes after administration of intrathecal opiate

• Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin

  day 1, 30 minutes after administration of intrathecal opiate

• Incidence of antihypertensive treatment after ephedrine administration

  day 1, 30 minutes after administration of intrathecal opiate

Study Arms (2)

Ephedrine

EXPERIMENTAL

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)

Drug: Ephedrine

Placebo

PLACEBO COMPARATOR

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.

Drug: Normal Saline Placebo

Interventions

Ephedrine DRUG

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.

Ephedrine

Normal Saline Placebo DRUG

Placebo will be administered at matching rate.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-55 years
• Requesting labor analgesia
• Able to provide informed written consent
• Category 1 fetal tracing prior to placement of neuraxial anesthesia

You may not qualify if:

• Refusal of neuraxial anesthesia
• History of hypertension
• Suspected pre-eclampsia
• Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount SInai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Ephedrine

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• James Leader

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Central Study Contacts

Daniel Katz, MD

CONTACT

212-241-7475; daniel.katz@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine Icahn School of Medicine at Mount Sinai Director of Education Mount Sinai HELPS Center

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)