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| ID | Type | Description | Link |
|---|---|---|---|
| F31NR018582-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Nova Biomedical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Capillary Lactate | Capillary lactate measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured within 10 minutes of the amniotic fluid lactate measurement. | At the time of amniotic fluid collection |
| Serum Lactate |
| Measure | Description | Time Frame |
|---|---|---|
| (Exploratory) Maternal Age | Maternal age in years | At the time of delivery |
| (Exploratory) Maternal BMI | Maternal body mass index (kg2/cm) | At the time of delivery |
Inclusion Criteria:
Exclusion Criteria:
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Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Kissler, PhD | University of Colorado Anschutz Medical Campus, College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Hospital | Aurora | Colorado | 80045 | United States |
Data sharing can be arranged by contacting the PI
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Plasma and Serum will be frozen and biobanked for future research.
Serum lactate measured using a POC device and analyzed using a laboratory assay
| At the time of amniotic fluid collection |
| Serum IL-6 | Serum IL-6 measured using a laboratory assay (multiplex) | At the time of amniotic fluid collection |
| (Exploratory) Neonatal Sex | Neonatal sex (male/female) | Identified by provider at time of delivery |
| (Exploratory) Neonatal Weight | Neonatal weight (g) | Measured by provider at time of delivery |
| (Exploratory) Perinatal Mood Disorders | 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 | During the prenatal period |
| (Exploratory) Length of Latent 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 | Immediately prior to labor |
| (Exploratory) Length of Active Labor | length of active labor in hours measured from the time of active labor onset identified by partograph, until birth | During labor |
| (Exploratory) Oxytocin Augmentation | Use of oxytocin (y/n) during labor | During labor (prior to birth) |
| (Exploratory) Fetal distress | Fetal distress identified as category 3 fetal heart tracing during labor (Y/N) | During labor |
| (Exploratory) Birth Outcome | Vaginal birth, cesarean birth, or instrumental vaginal birth | At the time of birth |
| (Exploratory) Postpartum Hemorrhage | Presence of postpartum hemorrhage (Y/N) >1000 ml of blood loss | Within the first hour after birth |
| (Exploratory) Estimated Blood Loss | Blood loss (ml) | Within the first hour after birth |