UCHealth Hospital
Aurora, Colorado, 80045, United States
NCT Number: NCT04251702
This observational study characterizes the relationship between amniotic fluid lactate and uterine electromyography during labor in healthy individuals at term planning a vaginal birth. Additional comparison measures and outcomes measures will be collected and analyzed as exploratory measures.
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Notify Me18 year–41 year
Female
Observational
Aurora, Colorado, 80045, United States
Elevated amniotic fluid lactate (AFL) and uterine electromyography (EMG) mathematically transformed to calculated the power density spectrum median frequency have been found separately to be associated with labor dystocia and cesarean birth. Similarly, recent research indicates that the cytokine IL-6 may play a critical role in labor onset and potentially labor progression. All three are hypothesized to reflect that uterine fatigue plays a role in the pathophysiology of labor dystocia for some women.
This study aims to characterize the relationship between these three measures to better understand the role of uterine fatigue in labor dystocia and triangulate biomarkers of fatigue that may lead to a better understanding of labor dystocia phenotypes.
In addition to the primary measures, comparison measures will be collected. For AFL comparison, venous whole blood lactate and capillary lactate will be collected and measured using both a point-of-care lactate meter (Stat Strip Lactate Meter, Nova Biomedical) and a table-top blood gas analyzer (Nova Prime). For EMG comparison, routine contraction monitoring data will be collected and compared to the EMG signal. IL-6 will be measured both in blood and amniotic fluid using a novel microsampling protocol. Three visual analog scales on women's experiences of fatigue, anxiety, and pain will also be administered.
Additional data will be collected from the medical record to perform exploratory and hypothesis generating analysis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During active labor (4-10cm) after rupture of membranes
Amniotic fluid lactate as measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured once during active labor (6-10cm) after rupture of membranes.
Time frame: 30 minutes after amniotic fluid collection during active labor (4-10cm) after rupture of membranes
Uterine electromyography measured using the Bloomlife Lovelace EMG monitor
Time frame: At the time of amniotic fluid collection
Participants indicate their level of fatigue on a 100 mm horizontal line anchored by "no fatigue at all" (0) and "the most serious fatigue imaginable" (100). The scale will be administered at the time of amniotic fluid collection.
Time frame: At the time of amniotic fluid collection
Amniotic fluid collected using a volumetric assisted microsampling device.
Time frame: At the time of amniotic fluid collection
Capillary lactate measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured within 10 minutes of the amniotic fluid lactate measurement.
Time frame: At the time of amniotic fluid collection
Serum lactate measured using a POC device and analyzed using a laboratory assay
Time frame: At the time of amniotic fluid collection
Serum IL-6 measured using a laboratory assay (multiplex)
Time frame: At the time of delivery
Maternal age in years
Time frame: At the time of delivery
Maternal body mass index (kg2/cm)
Time frame: Identified by provider at time of delivery
Neonatal sex (male/female)
Time frame: Measured by provider at time of delivery
Neonatal weight (g)
Time frame: During the prenatal period
Presence of perinatal mood disorders as identified by ICD 10 code, history of perinatal mood disorders recorded in the chart, or Edinburgh Postnatal Depression Score > 13
Time frame: Immediately prior to labor
length of latent labor in hours measured from the time the participant identifies labor onset through the time of active labor onset identified via partograph
Time frame: During labor
length of active labor in hours measured from the time of active labor onset identified by partograph, until birth
Time frame: During labor (prior to birth)
Use of oxytocin (y/n) during labor
Time frame: During labor
Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)
Time frame: At the time of birth
Vaginal birth, cesarean birth, or instrumental vaginal birth
Time frame: Within the first hour after birth
Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss
Time frame: Within the first hour after birth
Blood loss (ml)
University of Colorado, Denver
Other
Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management
Acronym: BUMP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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