LaborPhase 4NCT05873218
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
A Phase 4 study testing Ephedrine in people with Labor, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor
- What is being tested?
- Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2023to May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-55 years
- Requesting labor analgesia
- Able to provide informed written consent
- Category 1 fetal tracing prior to placement of neuraxial anesthesia
Who cannot join
- Refusal of neuraxial anesthesia
- History of hypertension
- Suspected pre-eclampsia
- Category 2 or 3 fetal tracing prior to placement of neuraxial anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount SInai
New York, New York, 10029
Daniel Katz, MD, daniel.Katz@montsinai.org
Daniel Katz
About this study
Official title: Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients
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:
Read more
- 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).
- Conditions
- Labor
- Being tested
- Ephedrine, Normal Saline Placebo
- Keywords
- Randomized Control Trial, Prophylactic Ephedrine, Fetal Heart Rate Tracing, Combined Spinal Epidural, Labor analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
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.
Normal Saline PlaceboDrug
Placebo will be administered at matching rate.
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine | Experimental | 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) Receives: Drug: Ephedrine |
| Placebo | Placebo comparator | 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. Receives: Drug: Normal Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1, 30 minutes after administration of intrathecal opiate
Secondary outcomes (10)
Incidence of uterine tetanic contractions
Incidence of uterine tetanic contractions after combined spinal epidural placement
Measured: 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
Measured: 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
Measured: 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
Measured: day 1, 30 minutes after administration of intrathecal opiate
Incidence of antihypertensive treatment after ephedrine administration
Incidence of antihypertensive treatment after ephedrine administration
Measured: 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
Measured: 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
Measured: day 1, 30 minutes after administration of intrathecal opiate
Average HR changes
Average HR changes 30 minutes after intrathecal opiate administration
Measured: 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
Measured: 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
Measured: End of study, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start26 Jun 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaborStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Katz, Icahn School of Medicine at Mount Sinai
- Investigators
- James Leader, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873218
- Sponsor's protocol ID
- STUDY-22-01334
- Status last verified
- May 2026
- First submitted
- 15 May 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be protected.