Effects of different medications on uterine and umbilical vessel function during cesarean deliveries
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 19 Years to 40 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04053478 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Toronto, Ontario
- 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
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.