Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
- Registration Number
- NCT05873218
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 135
- Women aged 18-55 years
- Requesting labor analgesia
- Able to provide informed written consent
- Category 1 fetal tracing prior to placement of neuraxial anesthesia
- Refusal of neuraxial anesthesia
- History of hypertension
- Suspected pre-eclampsia
- Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Normal Saline 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. Ephedrine 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)
- Primary Outcome Measures
Name Time Method Incidence of category II fetal heart rate tracing 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
- Secondary Outcome Measures
Name Time Method Incidence of fetal bradycardia day 1, 30 minutes after administration of intrathecal opiate Incidence of fetal bradycardia up to 30 minutes after administration of intrathecal opiate
Incidence of urgent/emergent cesarean delivery day 1, 30 minutes after administration of intrathecal opiate Incidence of urgent/emergent cesarean delivery within 30 minutes of intrathecal opiate administration
Number of patients with systolic blood pressure under 90 mmHG End of study, at 6 months Systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness
Incidence of hypotension 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
Average blood pressure changes 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
Incidence of uterine tetanic contractions day 1, 30 minutes after administration of intrathecal opiate Incidence of uterine tetanic contractions after combined spinal epidural placement
Incidence of antihypertensive treatment after ephedrine administration day 1, 30 minutes after administration of intrathecal opiate Incidence of antihypertensive treatment after ephedrine administration
Incidence of uterine hypertorus day 1, 30 minutes after administration of intrathecal opiate Incidence of uterine hypertorus up to 30 minutes after administration of intrathecal opiate
Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin 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
Average HR changes day 1, 30 minutes after administration of intrathecal opiate Average HR changes 30 minutes after intrathecal opiate administration
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount SInai
🇺🇸New york, New York, United States