Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04251702
Study type Observational
Source University of Colorado, Denver
Contact Katherine Kissler, PhD
Phone 303-724-4769
Email katherine.kissler@cuanschutz.edu
Status Recruiting
Phase
Start date August 21, 2023
Completion date July 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05560802 - Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO) N/A
Completed NCT03961165 - BUSCLAB - Buscopan to Prevent Slow Progress in Labor Phase 3
Not yet recruiting NCT05791630 - The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL) N/A
Recruiting NCT06405984 - Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE Early Phase 1
Completed NCT04551690 - Prevalence of COVID-19 (Coronavirus Disease 19) in Pregnant Women on Labor in a Public Hospital in Chile (COroNavirus diSease Covid-19 pandEmic iN ChilE)