An observational study in Labor (Obstetrics)--Complications and Labor; Dyscoordinate, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants aged 18 Years to 41 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Colorado, Denver · Observational
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 42 is below the median of 212 across 12 observational studies indexed under Dystocia.
Browse Dystocia studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Healthy laboring individuals with a Singleton Term fetus in the Vertex position. Patients requiring medical management of diabetes or hypertension will be excluded.
Amniotic Fluid Lactate
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: During active labor (4-10cm) after rupture of membranes
Median power density spectrum of uterine electromyography
Uterine electromyography measured using the Bloomlife Lovelace EMG monitor
Time frame: 30 minutes after amniotic fluid collection during active labor (4-10cm) after rupture of membranes
Visual analog scale for fatigue
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 IL-6
Amniotic fluid collected using a volumetric assisted microsampling device.
Time frame: At the time of amniotic fluid collection
Capillary Lactate
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
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
Serum IL-6 measured using a laboratory assay (multiplex)
Time frame: At the time of amniotic fluid collection
(Exploratory) Maternal Age
Maternal age in years
Time frame: At the time of delivery
(Exploratory) Maternal BMI
Maternal body mass index (kg2/cm)
Time frame: At the time of delivery
(Exploratory) Neonatal Sex
Neonatal sex (male/female)
Time frame: Identified by provider at time of delivery
(Exploratory) Neonatal Weight
Neonatal weight (g)
Time frame: Measured by provider at time of delivery
(Exploratory) Perinatal Mood Disorders
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: During the prenatal period
(Exploratory) Length of Latent 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: Immediately prior to labor
(Exploratory) Length of Active Labor
length of active labor in hours measured from the time of active labor onset identified by partograph, until birth
Time frame: During labor
(Exploratory) Oxytocin Augmentation
Use of oxytocin (y/n) during labor
Time frame: During labor (prior to birth)
(Exploratory) Fetal distress
Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)
Time frame: During labor
(Exploratory) Birth Outcome
Vaginal birth, cesarean birth, or instrumental vaginal birth
Time frame: At the time of birth
(Exploratory) Postpartum Hemorrhage
Presence of postpartum hemorrhage (Y/N) \>1000 ml of blood loss
Time frame: Within the first hour after birth
(Exploratory) Estimated Blood Loss
Blood loss (ml)
Time frame: Within the first hour after birth
Plan to share: No — Data sharing can be arranged by contacting the PI
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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