Icahn School of Medicine at Mount SInai
New York, 10029, United States
Location status: Recruiting
NCT Number: NCT05873218
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).
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Phase 4
New York, 10029, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 will be administered at matching rate.
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of uterine tetanic contractions after combined spinal epidural placement
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of uterine hypertorus up to 30 minutes after administration of intrathecal opiate
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of fetal bradycardia up to 30 minutes after administration of intrathecal opiate
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin up to 30 minutes after administration of intrathecal opiate
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of antihypertensive treatment after ephedrine administration
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of urgent/emergent cesarean delivery within 30 minutes of intrathecal opiate administration
Time frame: day 1, 30 minutes after administration of intrathecal opiate
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
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Average HR changes 30 minutes after intrathecal opiate administration
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Average blood pressure changes 30 minutes after intrathecal opiate administration of systolic and diastolic blood pressure
Time frame: End of study, at 6 months
Systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness
Contact information is provided by the study sponsor or research team.
Icahn School of Medicine at Mount Sinai
Other
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients
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