Effects of different medications on uterine and umbilical vessel function during cesarean deliveries
Official title: Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study
Run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT04053478 · Data updated 2026-11-12
This study is testing how different medications used during cesarean deliveries affect blood flow in the uterus and umbilical cord to see which ones are best for keeping mothers and babies healthy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 40 Years |
| Sex | Women only |
| Enrollment | 144 (estimated) |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | July 8, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT04053478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women aged 19-40, at 37-41 weeks of gestation, who are undergoing elective cesarean deliveries under spinal anesthesia.
✕Probably not a fit
Patients who are in labor, require general anesthesia, or have certain medical conditions affecting uterine contractility may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how various vasopressors, including ephedrine, phenylephrine, norepinephrine, and vasopressin, affect the contractility of human myometrium and umbilical vessels in an in-vitro setting. By isolating these tissues, the research aims to eliminate clinical confounding variables and directly compare the effects of these medications on uteroplacental blood flow and fetal health. The findings could provide critical insights into the optimal management of hypotension during cesarean deliveries, which is a common complication affecting many mothers and their newborns.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypotension during cesarean deliveries, enhancing maternal and neonatal outcomes.
How similar studies have gone: While there have been studies on vasopressor use in obstetrics, this specific in-vitro approach to directly compare their effects on myometrial and umbilical vessel function is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who give written consent to participate in this study * Patients with gestational age 37-41 weeks * Patients of 19-40 years * Non-laboring patients, not exposed to exogenous oxytocin * Patients requiring elective primary or first repeat caesarean delivery * Patients undergoing caesarean delivery under spinal anesthesia Exclusion Criteria: * Patients who refuse to give written informed consent * Patients who require general anesthesia * Patients in labor and those receiving oxytocin for induction of labor * Emergency caesarean delivery in labor * Patients who have had previous uterine surgery or \>1 previous caesarean delivery * Patients with any condition predisposing to uterine atony * Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetolol or magnesium sulfate.
Where it's running
-
Mount Sinai Hospital
Toronto, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
- Study coordinator: Mrinalini Balki, MD
- Email: mrinalini.balki@uhn.ca
- Phone: 416-586-4800
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cardiac Arrest: Using Ultrasound to Find Hidden Blood Flow
This study tests whether patients who have out-of-hospital cardiac arrest but no pulse still show some blood flow on ultrasound and whether that finding relates to survival.
-
Perfusion Index as a Predictor of Spinal Anesthesia–Induced Hypotension in Day-Case Knee Arthroscopy
This study looks to see if a baseline perfusion index can predict low blood pressure after spinal anesthesia in healthy adults having knee arthroscopy.
-
Pupil light reflex to predict low blood pressure after spinal anesthesia in cesarean deliveries
Doctors want to see if a quick eye-pupil test done before spinal anesthesia can predict who might develop low blood pressure after a cesarean delivery.
-
Pulse palpation vs arterial blood pressure in circulatory shock
This study tests how well feeling for a pulse at typical sites matches the actual arterial blood pressure in adults with circulatory shock or risk of failure.
-
Predicting low blood pressure from spinal anesthesia during cesarean section
This study will test whether body-shape measures (body roundness index and waist circumference) and simple heart/blood pressure indexes can help predict which full-term women having a cesarean with spinal anesthesia will develop low blood pressure.
-
Mindfulness-based breathing before spinal anesthesia for elective cesarean delivery
This trial will test whether a 5-minute mindfulness slow-breathing exercise just before spinal anesthesia can reduce blood pressure drops and anxiety in pregnant women having elective cesarean delivery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.