Biomarkers of Uterine Muscle Physiology (BUMP)

Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management

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.

Study Overview

• Status: Recruiting
• Conditions: Labor (Obstetrics)--Complications; Labor; Dyscoordinate

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.

• Study Type: Observational
• Enrollment (Estimated): 46

Contacts and Locations

• Study Contact: Name: Katherine Kissler, PhD; Phone Number: 303-724-4769; Email: katherine.kissler@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • UCHealth Hospital
      • Contact: Jocelyn Phipers, MS; Email: jocelyn.phipers@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Low-Risk Individuals in Labor; Healthy laboring individuals with a Singleton Term fetus in the Vertex position. Patients requiring medical management of diabetes or hypertension will be excluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	At the time of amniotic fluid collection
Amniotic fluid IL-6	Amniotic fluid collected using a volumetric assisted microsampling device.	At the time of amniotic fluid collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of amniotic fluid collection
Serum Lactate	Serum lactate measured using a POC device and analyzed using a laboratory assay	At the time of amniotic fluid collection
Serum IL-6	Serum IL-6 measured using a laboratory assay (multiplex)	At the time of amniotic fluid collection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Exploratory) Maternal Age	Maternal age in years	At the time of delivery
(Exploratory) Maternal BMI	Maternal body mass index (kg2/cm)	At the time of delivery
(Exploratory) Neonatal Sex	Neonatal sex (male/female)	Identified by provider at time of delivery
(Exploratory) Neonatal Weight	Neonatal weight (g)	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	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	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	During labor
(Exploratory) Oxytocin Augmentation	Use of oxytocin (y/n) during labor	During labor (prior to birth)
(Exploratory) Fetal distress	Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)	During labor
(Exploratory) Birth Outcome	Vaginal birth, cesarean birth, or instrumental vaginal birth	At the time of birth
(Exploratory) Postpartum Hemorrhage	Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss	Within the first hour after birth
(Exploratory) Estimated Blood Loss	Blood loss (ml)	Within the first hour after birth

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Nursing Research (NINR); Nova Biomedical
• Investigators: Principal Investigator: Katherine Kissler, PhD, University of Colorado Anschutz Medical Campus, College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cesarean delivery; labor dystocia; uterine monitoring
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Dystocia
• Other Study ID Numbers: 19-0307; F31NR018582-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing can be arranged by contacting the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No