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NCT05873218 · ClinicalTrials.gov registry record · Phase 4
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
A Phase 4 study of Labor, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 135
- Enrollment target
- 1
- Study location
NCT05873218: Recruiting Phase 4 study of Labor, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05873218 is a Phase 4 study of Labor that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 135 participants, below the 219-participant average among 4 other Labor trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05873218, a Phase 4 study of Labor, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 135 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Incidence of category II fetal heart rate tracing up to 30 minutes after administration of intrathecal opiate
Conditions Studied
Interventions
- DRUG Ephedrine
- DRUG Normal Saline Placebo
Study Locations (1)
New York
- Icahn School of Medicine at Mount SInai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2026-04 |
| Phase | Phase 4 |
What NCT05873218 shows while recruiting
NCT05873218 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 4 other Labor trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Labor appearing as the primary indexed condition, and to 2 interventions - of which Ephedrine is the first listed.
NCT05873218 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05873218 about?
NCT05873218 is a clinical study titled "Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE". 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 stud...
What is the current status of trial NCT05873218?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 135 participants. The study started on 2023-06-26. Estimated completion is 2026-04.
What conditions does trial NCT05873218 study?
This clinical trial studies the following conditions: Labor.
What interventions are being tested in trial NCT05873218?
The interventions under investigation include: Ephedrine (DRUG), Normal Saline Placebo (DRUG).
Who is sponsoring clinical trial NCT05873218?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05873218 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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