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

NCT ID: NCT05873218

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2026-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Ephedrine

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline Placebo

Intervention Type: DRUG

Placebo will be administered at matching rate.

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.

Intervention Type: DRUG

Normal Saline Placebo

Placebo will be administered at matching rate.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Daniel Katz

Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine Icahn School of Medicine at Mount Sinai Director of Education Mount Sinai HELPS Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Leader

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount SInai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel Katz, MD

Role: CONTACT

daniel.katz@mountsinai.org

212-241-7475

Facility Contacts

Daniel Katz, MD

Role: primary

daniel.Katz@montsinai.org

Other Identifiers

STUDY-22-01334

Identifier Type: -

Identifier Source: org_study_id