A Phase 4 interventional study of Ephedrine and Normal Saline Placebo in Labor, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Prevention
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:
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).
Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Ephedrine
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.
Drug: Normal Saline Placebo
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.
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
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of uterine tetanic contractions
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
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
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
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
Incidence of antihypertensive treatment after ephedrine administration
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Incidence of urgent/emergent cesarean delivery
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
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
Average HR changes 30 minutes after intrathecal opiate administration
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Average blood pressure changes
Average blood pressure changes 30 minutes after intrathecal opiate administration of systolic and diastolic blood pressure
Time frame: day 1, 30 minutes after administration of intrathecal opiate
Number of patients with systolic blood pressure under 90 mmHG
Systolic blood pressure under 90 mmHG, or symptoms of hypotension such as light headedness
Time frame: End of study, at 6 months
Plan to share: No — Individual participant data will be protected.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Icahn School of Medicine at Mount Sinai