Biomarkers of Uterine Muscle Physiology

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 30, 2020

Keywords

ClinConnect Summary

**Summary of Clinical Trial: Biomarkers of Uterine Muscle Physiology**

This clinical trial is looking at how certain markers in amniotic fluid relate to the activity of the uterus during labor in healthy pregnant women who are about to give birth. Specifically, the study will measure lactate levels in the amniotic fluid and monitor uterine activity using a method called electromyography. This trial aims to better understand how the uterus works during labor, which could help improve care for women experiencing complications during childbirth.

To be eligible for this study, participants must be women aged between 18 and 41 years who are at term in their pregnancy (between 37 and 41 weeks). They should be expecting a single baby that is positioned head down. Women with certain health conditions, such as diabetes or high blood pressure that require medication, or any fetal complications, will not be able to participate. If you join the study, you can expect to undergo some additional tests while in labor, and your information will be collected for further analysis. This research is currently recruiting participants, so it’s a great opportunity to contribute to our understanding of labor and delivery.

Gender

FEMALE

Eligibility criteria

• 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.