Using ephedrine to improve fetal heart monitoring during labor
Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After Combined Spinal Epidural on Laboring Parturients
This study tests if giving ephedrine to women in labor who are using spinal-epidural anesthesia can help improve fetal heart monitoring and reduce low blood pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05873218 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of prophylactic ephedrine on fetal heart rate tracings and uterine contractions in women receiving combined spinal-epidural anesthesia for labor analgesia. The research aims to determine if administering ephedrine can reduce the incidence of category II fetal heart rate tracings and low blood pressure, which are known side effects of this anesthesia method. Participants will be randomly assigned to receive either ephedrine or a normal saline placebo. The study is significant as it explores an investigational use of ephedrine in this context, which has not been routinely practiced.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-55 who are requesting labor analgesia and have a category I fetal tracing prior to anesthesia placement.
Not a fit: Patients who refuse neuraxial anesthesia or have a history of hypertension or category II or III fetal tracings prior to anesthesia placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance fetal monitoring and improve outcomes during labor for patients receiving neuraxial anesthesia.
How similar studies have performed: While the use of ephedrine in this context is investigational, similar studies have explored its effects on blood pressure and fetal heart rate, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount SInai — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Daniel Katz, MD
- Email: daniel.katz@mountsinai.org
- Phone: 212-241-7475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.