Biomarkers of Uterine Fatigue
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|ClinicalTrials.gov Identifier: NCT04251702|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 13, 2020
|Condition or disease|
|Labor (Obstetrics)--Complications Labor; Dyscoordinate|
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. Both 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 the two 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. 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 Type :||Observational|
|Estimated Enrollment :||46 participants|
|Official Title:||Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||October 2020|
Healthy Low-Risk Nulliparous Women in Spontaneous Labor
Healthy Nulliparous women with a Singleton Term fetus in the Vertex position in spontaneous labor.
- Amniotic Fluid Lactate [ Time Frame: During active labor (6-10cm) 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.
- Median power density spectrum of uterine electromyography [ Time Frame: One hour after amniotic fluid collection during active labor (6-10cm) after rupture of membranes ]Uterine electromyography measured using iWorx B3G biorecorder and galvanic skin resistance monitor. Signal is recorded for one hour after amniotic fluid collection during active labor (6-10cm) after rupture of membranes
- Visual analog scale for fatigue [ Time Frame: At the time of amniotic fluid collection (Pre-labor) ]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.
- Capillary Lactate [ Time Frame: Active Labor, within 10 minutes of the amniotic fluid lactate measurement ]Capillary lactate measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured within 10 minutes of the amniotic fluid lactate measurement.
- (Exploratory) Maternal Age [ Time Frame: At the time of delivery ]Maternal age in years
- (Exploratory) Maternal BMI [ Time Frame: At the time of delivery ]Maternal body mass index (kg2/cm)
- (Exploratory) Neonatal Sex [ Time Frame: Identified by provider at time of delivery ]Neonatal sex (male/female)
- (Exploratory) Neonatal Weight [ Time Frame: Measured by provider at time of delivery ]Neonatal weight (g)
- (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
- (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
- (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
- (Exploratory) Oxytocin Augmentation [ Time Frame: During labor (prior to birth) ]Use of oxytocin (y/n) during labor
- (Exploratory) Fetal distress [ Time Frame: During labor ]Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)
- (Exploratory) Birth Outcome [ Time Frame: At the time of birth ]Vaginal birth, cesarean birth, or instrumental vaginal birth
- (Exploratory) Postpartum Hemorrhage [ Time Frame: Within the first hour after birth ]Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss
- (Exploratory) Estimated Blood Loss [ Time Frame: Within the first hour after birth ]Blood loss (ml)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251702
|Contact: Katherine Kissler, MSfirstname.lastname@example.org|
|Principal Investigator:||Katherine Kissler, MS||University of Colorado Anschutz Medical Campus, College of Nursing|