Effects of combined spinal-epidural analgesia on uterine and umbilical artery blood flow in laboring women
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)
This study is testing how a pain relief method used during labor affects blood flow in the uterus and umbilical cord to see if it impacts the baby's heart rate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06655675 on ClinicalTrials.gov |
What this trial studies
This study investigates the changes in blood flow indices of the uterine and umbilical arteries before and after administering combined spinal-epidural (CSE) analgesia in women during labor. CSE is a common method for providing rapid pain relief, but it carries a risk of abnormal fetal heart rates. The study aims to understand the relationship between CSE and fetal heart rate changes by utilizing ultrasound to monitor blood flow. The findings could help optimize labor analgesia practices and improve maternal and fetal outcomes.
Who should consider this trial
Good fit: Ideal candidates include term pregnant women in active labor who are requesting analgesia and have no significant fetal complications.
Not a fit: Patients with known spinal deformities, previous back surgeries, or a BMI over 50 kg/㎡ may not benefit from this study due to technical challenges.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of pain management during labor for both mothers and their babies.
How similar studies have performed: Previous studies have shown varying results regarding the effects of CSE on fetal heart rates, indicating that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Term pregnant patients requesting labor analgesia * Singleton pregnancy * Term pregnant patients in active labor * ASA\<4 * No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE * Patients with and without diagnosed hypertensive disorders of pregnancy Exclusion Criteria: * Refusal to consent for the study * Known spinal deformities * Previous back instrumentation * Patients with BMI\>50 kg/㎡ due to anticipated technical challenges in Doppler studies
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.