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

Labor Clinical Trial

Official title:

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873218
• Other study ID #: STUDY-22-01334
• Status: Recruiting
• Phase: Phase 4
• Start date: June 26, 2023
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Daniel Katz, MD
• Phone: 212-241-7475
• Email: daniel.katz[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount SInai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of uterine tetanic contractions	Incidence of uterine tetanic contractions after combined spinal epidural placement	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of uterine hypertorus	Incidence of uterine hypertorus up to 30 minutes after administration of intrathecal opiate	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of fetal bradycardia	Incidence of fetal bradycardia up to 30 minutes after administration of intrathecal opiate	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin	Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin up to 30 minutes after administration of intrathecal opiate	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of antihypertensive treatment after ephedrine administration	Incidence of antihypertensive treatment after ephedrine administration	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of urgent/emergent cesarean delivery	Incidence of urgent/emergent cesarean delivery within 30 minutes of intrathecal opiate administration	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Incidence of hypotension	Incidence of hypotension as defined as systolic blood pressure decrease of 20% versus baseline, systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Average HR changes	Average HR changes 30 minutes after intrathecal opiate administration	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Average blood pressure changes	Average blood pressure changes 30 minutes after intrathecal opiate administration of systolic and diastolic blood pressure	day 1, 30 minutes after administration of intrathecal opiate
Secondary	Number of patients with systolic blood pressure under 90 mmHG	Systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness	End of study, at 6 months