Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ephedrine, Normal Saline Placebo.
- Who it may be relevant to
- Registry conditions: Labor. Basic parameters: 18 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients
Overview
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).
Interventions
- 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. - Drug Normal Saline Placebo
Placebo will be administered at matching rate.
Primary outcome measures
- Incidence of category II fetal heart rate tracing [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
Secondary outcome measures (10)
- Incidence of uterine tetanic contractions [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Incidence of uterine hypertorus [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Incidence of fetal bradycardia [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Incidence of rescue administration of ephedrine, terbutaline, or nitroglycerin [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 [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Incidence of hypotension [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Average HR changes [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Average blood pressure changes [Time frame: day 1, 30 minutes after administration of intrathecal opiate]
- Number of patients with systolic blood pressure under 90 mmHG [Time frame: End of study, at 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Icahn School of Medicine at Mount SInai — New York
Identifiers
NCT: NCT05873218 · STUDY-22-01334