NCT05873218 Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
| NCT ID | NCT05873218 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-06-26 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-06-26 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
James Leader
STUDY DIRECTOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05873218 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05873218 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05873218 currently recruiting?
Yes, NCT05873218 is actively recruiting participants. Contact the research team at daniel.katz@mountsinai.org for enrollment information.
Where is the NCT05873218 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05873218 clinical trial?
NCT05873218 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is James Leader at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 100 participants.