Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE
Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · May 23, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a medication called ephedrine can help reduce certain heart rate patterns in unborn babies and low blood pressure in mothers during labor. When women receive a type of pain relief called combined spinal and epidural anesthesia (CSE), it can sometimes lead to changes in the baby's heart rate, particularly a pattern called Category II tracing. This study aims to see if giving a small preventive dose of ephedrine before the anesthesia can lower the chances of these heart rate changes and low blood pressure, which can affect the care during labor.
To participate in this trial, women must be between 18 and 55 years old, be requesting pain relief during labor, and have a reassuring heart rate pattern for the baby before receiving the anesthesia. However, women who have high blood pressure, suspect pre-eclampsia, or already have concerning heart rate patterns for their baby are not eligible. If you join the study, you will receive the medication and be monitored closely to see how it affects your labor experience and the baby's heart rate. This is the first time researchers are looking into this use of ephedrine, so your participation could help improve care for future laboring patients.
Gender
FEMALE
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
About Icahn School Of Medicine At Mount Sinai
The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
James Leader
Study Director
Icahn School of Medicine at Mount Sinai
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported