Biomarkers of Uterine Muscle Physiology

Labor (Obstetrics)--Complications Clinical Trial

— BUMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251702
• Other study ID #: 19-0307
• Secondary ID: F31NR018582-01
• Status: Recruiting
• Start date: August 21, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Katherine Kissler, PhD
• Phone: 303-724-4769
• Email: katherine.kissler[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystocia
• Labor (Obstetrics)--Complications
• Labor; Dyscoordinate

Locations

Country	Name	City	State
United States	UCHealth Hospital	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Nursing Research (NINR), Nova Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	(Exploratory) Maternal Age	Maternal age in years	At the time of delivery
Other	(Exploratory) Maternal BMI	Maternal body mass index (kg2/cm)	At the time of delivery
Other	(Exploratory) Neonatal Sex	Neonatal sex (male/female)	Identified by provider at time of delivery
Other	(Exploratory) Neonatal Weight	Neonatal weight (g)	Measured by provider at time of delivery
Other	(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
Other	(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
Other	(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
Other	(Exploratory) Oxytocin Augmentation	Use of oxytocin (y/n) during labor	During labor (prior to birth)
Other	(Exploratory) Fetal distress	Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)	During labor
Other	(Exploratory) Birth Outcome	Vaginal birth, cesarean birth, or instrumental vaginal birth	At the time of birth
Other	(Exploratory) Postpartum Hemorrhage	Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss	Within the first hour after birth
Other	(Exploratory) Estimated Blood Loss	Blood loss (ml)	Within the first hour after birth
Primary	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
Primary	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
Primary	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
Primary	Amniotic fluid IL-6	Amniotic fluid collected using a volumetric assisted microsampling device.	At the time of amniotic fluid collection
Secondary	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
Secondary	Serum Lactate	Serum lactate measured using a POC device and analyzed using a laboratory assay	At the time of amniotic fluid collection
Secondary	Serum IL-6	Serum IL-6 measured using a laboratory assay (multiplex)	At the time of amniotic fluid collection