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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873218
Other study ID # STUDY-22-01334
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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