Clinical trial NCT05873218: Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Official title: Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Labor
Keywords: Randomized Control Trial
Prophylactic Ephedrine
Fetal Heart Rate Tracing
Combined Spinal Epidural
Labor analgesia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Incidence of category II fetal heart rate tracing
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
Secondary outcomes:
measure: Incidence of uterine tetanic contractions
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of uterine hypertorus
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of fetal bradycardia
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of antihypertensive treatment after ephedrine administration
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of urgent/emergent cesarean delivery
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Incidence of hypotension
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Average HR changes
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Average blood pressure changes
timeFrame: day 1, 30 minutes after administration of intrathecal opiate
measure: Number of patients with systolic blood pressure under 90 mmHG
timeFrame: End of study, at 6 months
Other outcomes:
Locations:
city: New york
country: United States
facility: Icahn School of Medicine at Mount SInai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: James Leader
role: STUDY_DIRECTOR
References: