Understanding uterine muscle physiology during labor
Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management
This study looks at how certain markers in the body relate to uterine muscle activity during labor to see if they can help understand and improve difficult labors in healthy women planning a vaginal birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04251702 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between amniotic fluid lactate levels and uterine electromyography in healthy individuals at term who are planning a vaginal birth. It aims to explore how these measures, along with the cytokine IL-6, may indicate uterine fatigue and its role in labor dystocia. By collecting and analyzing various biomarkers and patient-reported outcomes, the study seeks to better characterize labor dystocia phenotypes. Additional data from medical records will also be utilized for exploratory analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy pregnant women aged 18-41, at term gestation with a single fetus in a vertex presentation.
Not a fit: Patients with pre-existing or gestational diabetes or hypertension requiring medical management may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of labor dystocia, potentially reducing the rates of cesarean deliveries.
How similar studies have performed: While the specific combination of biomarkers being studied is novel, previous research has indicated that individual measures like amniotic fluid lactate and uterine EMG have been associated with labor complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maternal age: 18-41 years at the due date * Term gestation: 37-41 weeks estimated gestational age (EGA) * Single fetus in a vertex presentation: Pregnancy with only one fetus that is in a head down position with the occiput leading into the pelvis upon admission to the hospital. Exclusion Criteria: * Pre-existing or gestational diabetes requiring medical management: The diagnosis of diabetes of any kind requiring management with medications including but not limited to insulin, glyburide, and metformin as indicated in the health record. * Pre-existing or gestational hypertension or pre-eclampsia requiring medical management: The diagnosis of hypertension of any kind requiring management with medications including but not limited to long-term hypertension management such as methyldopa and short-term or emergency hypertension management such as labetalol or magnesium sulfate as indicated in the health record. * Suspected fetal anomaly or intrauterine growth restriction: Any diagnosed fetal anomalies or intrauterine growth restriction as indicated in the health record. * Use of amnioinfusion prior to sample collection: Amnioinfusion, the infusion of fluids into the uterus using an intrauterine catheter may affect AFL concentrations. Any amnioinfusion prior to sample collection will exclude participants from continued participation. * Fetal distress prior to or during sample collection: Category 3 fetal heart tracing as defined by the National Institute of Child Health and Development22, absent fetal heart rate variability with recurrent late deceleration, recurrent variable decelerations, bradycardia, or sinusoidal rhythm.
Where this trial is running
Aurora, Colorado
- UCHealth Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Katherine Kissler, PhD — University of Colorado Anschutz Medical Campus, College of Nursing
- Study coordinator: Katherine Kissler, PhD
- Email: katherine.kissler@cuanschutz.edu
- Phone: 303-724-4769
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.