Effects of combined spinal-epidural analgesia on uterine and umbilical artery blood flow in laboring women
Official title: Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART I and PART II)
Run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · NCT06655675 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 54 (estimated) |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | October 30, 2024 |
| Main results expected | January 2026 |
| Study ends | January 2026 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT06655675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include term pregnant women in active labor who are requesting analgesia and have no significant fetal complications.
✕Probably 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.
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 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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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.
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Dural Puncture Epidural (DPE) Technique in Labor Analgesia
This observational study at Ohio State tests whether the DPE method can reliably reveal CSF and improve epidural placement during labor without injecting medication.
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Midwife-guided Birth Affirmation Cards for Primigravidas
This study tests whether midwife-guided birth affirmation cards can shorten labor, reduce pain, and improve feelings of control and support for first-time mothers.
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Tramadol versus paracetamol versus placebo for pain relief and labor length in first-time mothers
This trial will try IV tramadol, IV paracetamol, or saline to see which gives better pain relief and changes active labor length for first-time mothers in active labor.
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Left-side versus lying on your back to shorten the active phase of labor
This trial tests whether staying on your left side instead of lying on your back shortens the active phase of labor for first-time mothers at term.
-
TENS for pain relief during active labor
This trial will try using a TENS device versus a sham to see if it lowers pain for first-time moms during the active phase of labor.
-
PIEB versus CEI for epidural labor pain relief
This trial will test whether programmed intermittent epidural boluses (PIEB) or a continuous epidural infusion (CEI), each combined with patient-controlled epidural analgesia (PCEA), works better for pain relief during labor in women having vaginal 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.