Clinical trial NCT04251702: Biomarkers of Uterine Muscle Physiology
Official title: Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Labor (Obstetrics)--Complications
Labor; Dyscoordinate
Keywords: labor dystocia
cesarean delivery
uterine monitoring
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Nova Biomedical
First posted: 2020-02-05
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Amniotic Fluid Lactate
timeFrame: During active labor (4-10cm) after rupture of membranes
measure: Median power density spectrum of uterine electromyography
timeFrame: 30 minutes after amniotic fluid collection during active labor (4-10cm) after rupture of membranes
measure: Visual analog scale for fatigue
timeFrame: At the time of amniotic fluid collection
measure: Amniotic fluid IL-6
timeFrame: At the time of amniotic fluid collection
Secondary outcomes:
measure: Capillary Lactate
timeFrame: At the time of amniotic fluid collection
measure: Serum Lactate
timeFrame: At the time of amniotic fluid collection
measure: Serum IL-6
timeFrame: At the time of amniotic fluid collection
Other outcomes:
measure: (Exploratory) Maternal Age
timeFrame: At the time of delivery
measure: (Exploratory) Maternal BMI
timeFrame: At the time of delivery
measure: (Exploratory) Neonatal Sex
timeFrame: Identified by provider at time of delivery
measure: (Exploratory) Neonatal Weight
timeFrame: Measured by provider at time of delivery
measure: (Exploratory) Perinatal Mood Disorders
timeFrame: During the prenatal period
measure: (Exploratory) Length of Latent Labor
timeFrame: Immediately prior to labor
measure: (Exploratory) Length of Active Labor
timeFrame: During labor
measure: (Exploratory) Oxytocin Augmentation
timeFrame: During labor (prior to birth)
measure: (Exploratory) Fetal distress
timeFrame: During labor
measure: (Exploratory) Birth Outcome
timeFrame: At the time of birth
measure: (Exploratory) Postpartum Hemorrhage
timeFrame: Within the first hour after birth
measure: (Exploratory) Estimated Blood Loss
timeFrame: Within the first hour after birth
Locations:
city: Aurora
country: United States
facility: UCHealth Hospital
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz Medical Campus, College of Nursing
name: Katherine Kissler, PhD
role: PRINCIPAL_INVESTIGATOR
References: