Biomarkers of Uterine Muscle Physiology

Completed

Conditions studied: Labor (Obstetrics)--Complications, Labor; Dyscoordinate

In brief

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.

Key facts

Study ID

NCT04251702

Run by

University of Colorado, Denver

People needed

42

Starts

2023-08-21

Expected to finish

2025-12-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 41. Sex: female. Healthy volunteers: accepted.

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.

Where it is running

• UCHealth Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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