Biomarkers of Uterine Muscle Physiology

NCT04251702 | Completed DMC

• 2 other identifiers: 19-0307F31NR018582-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor (Obstetrics)--Complications; Labor; Dyscoordinate

Keywords

labor dystocia; cesarean delivery; uterine monitoring

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Capillary Lactate

  At the time of amniotic fluid collection

• Serum Lactate

  At the time of amniotic fluid collection

• Serum IL-6

  At the time of amniotic fluid collection

Other Outcomes (12)

• (Exploratory) Maternal Age

  At the time of delivery

• (Exploratory) Maternal BMI

  At the time of delivery

• (Exploratory) Neonatal Sex

  Identified by provider at time of delivery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Nursing Research (NINR): collaborator
• Nova Biomedical: collaborator

Study Sites (1)

UCHealth Hospital

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and Serum will be frozen and biobanked for future research.

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Katherine Kissler, PhD

  University of Colorado Anschutz Medical Campus, College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: August 21, 2023
• Primary Completion: March 20, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)