Skip to main content
OpenTrials
Completed

NCT Number: NCT04251702

Biomarkers of Uterine Muscle Physiology

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

UCHealth Hospital

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Amniotic Fluid Lactate

    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.

  2. Median power density spectrum of uterine electromyography

    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

  3. Visual analog scale for fatigue

    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.

  4. Amniotic fluid IL-6

    Time frame: At the time of amniotic fluid collection

    Amniotic fluid collected using a volumetric assisted microsampling device.

Secondary outcomes

  1. Capillary Lactate

    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.

  2. Serum Lactate

    Time frame: At the time of amniotic fluid collection

    Serum lactate measured using a POC device and analyzed using a laboratory assay

  3. Serum IL-6

    Time frame: At the time of amniotic fluid collection

    Serum IL-6 measured using a laboratory assay (multiplex)

Other outcomes

  1. (Exploratory) Maternal Age

    Time frame: At the time of delivery

    Maternal age in years

  2. (Exploratory) Maternal BMI

    Time frame: At the time of delivery

    Maternal body mass index (kg2/cm)

  3. (Exploratory) Neonatal Sex

    Time frame: Identified by provider at time of delivery

    Neonatal sex (male/female)

  4. (Exploratory) Neonatal Weight

    Time frame: Measured by provider at time of delivery

    Neonatal weight (g)

  5. (Exploratory) Perinatal Mood Disorders

    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

  6. (Exploratory) Length of Latent Labor

    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

  7. (Exploratory) Length of Active Labor

    Time frame: During labor

    length of active labor in hours measured from the time of active labor onset identified by partograph, until birth

  8. (Exploratory) Oxytocin Augmentation

    Time frame: During labor (prior to birth)

    Use of oxytocin (y/n) during labor

  9. (Exploratory) Fetal distress

    Time frame: During labor

    Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)

  10. (Exploratory) Birth Outcome

    Time frame: At the time of birth

    Vaginal birth, cesarean birth, or instrumental vaginal birth

  11. (Exploratory) Postpartum Hemorrhage

    Time frame: Within the first hour after birth

    Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss

  12. (Exploratory) Estimated Blood Loss

    Time frame: Within the first hour after birth

    Blood loss (ml)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Nova Biomedical

Registry information

Official study title

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

Acronym: BUMP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2020
Registry last updated
May 4, 2026

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.

Published trials that share one or more normalized conditions with this study.