Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT04251702
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2020-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Uterine Muscle Physiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004420', 'term': 'Dystocia'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma and Serum will be frozen and biobanked for future research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '(Exploratory) Maternal Age', 'timeFrame': 'At the time of delivery', 'description': 'Maternal age in years'}, {'measure': '(Exploratory) Maternal BMI', 'timeFrame': 'At the time of delivery', 'description': 'Maternal body mass index (kg2/cm)'}, {'measure': '(Exploratory) Neonatal Sex', 'timeFrame': 'Identified by provider at time of delivery', 'description': 'Neonatal sex (male/female)'}, {'measure': '(Exploratory) Neonatal Weight', 'timeFrame': 'Measured by provider at time of delivery', 'description': 'Neonatal weight (g)'}, {'measure': '(Exploratory) Perinatal Mood Disorders', 'timeFrame': 'During the prenatal period', 'description': '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'}, {'measure': '(Exploratory) Length of Latent Labor', 'timeFrame': 'Immediately prior to labor', 'description': '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'}, {'measure': '(Exploratory) Length of Active Labor', 'timeFrame': 'During labor', 'description': 'length of active labor in hours measured from the time of active labor onset identified by partograph, until birth'}, {'measure': '(Exploratory) Oxytocin Augmentation', 'timeFrame': 'During labor (prior to birth)', 'description': 'Use of oxytocin (y/n) during labor'}, {'measure': '(Exploratory) Fetal distress', 'timeFrame': 'During labor', 'description': 'Fetal distress identified as category 3 fetal heart tracing during labor (Y/N)'}, {'measure': '(Exploratory) Birth Outcome', 'timeFrame': 'At the time of birth', 'description': 'Vaginal birth, cesarean birth, or instrumental vaginal birth'}, {'measure': '(Exploratory) Postpartum Hemorrhage', 'timeFrame': 'Within the first hour after birth', 'description': 'Presence of postpartum hemorrhage (Y/N) \\>1000 ml of blood loss'}, {'measure': '(Exploratory) Estimated Blood Loss', 'timeFrame': 'Within the first hour after birth', 'description': 'Blood loss (ml)'}], 'primaryOutcomes': [{'measure': 'Amniotic Fluid Lactate', 'timeFrame': 'During active labor (4-10cm) after rupture of membranes', 'description': '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.'}, {'measure': 'Median power density spectrum of uterine electromyography', 'timeFrame': '30 minutes after amniotic fluid collection during active labor (4-10cm) after rupture of membranes', 'description': 'Uterine electromyography measured using the Bloomlife Lovelace EMG monitor'}, {'measure': 'Visual analog scale for fatigue', 'timeFrame': 'At the time of amniotic fluid collection', 'description': '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.'}, {'measure': 'Amniotic fluid IL-6', 'timeFrame': 'At the time of amniotic fluid collection', 'description': 'Amniotic fluid collected using a volumetric assisted microsampling device.'}], 'secondaryOutcomes': [{'measure': 'Capillary Lactate', 'timeFrame': 'At the time of amniotic fluid collection', 'description': 'Capillary lactate measured using the handheld StatStrip Lactate Meter (Nova Biomedical). This will be measured within 10 minutes of the amniotic fluid lactate measurement.'}, {'measure': 'Serum Lactate', 'timeFrame': 'At the time of amniotic fluid collection', 'description': 'Serum lactate measured using a POC device and analyzed using a laboratory assay'}, {'measure': 'Serum IL-6', 'timeFrame': 'At the time of amniotic fluid collection', 'description': 'Serum IL-6 measured using a laboratory assay (multiplex)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['labor dystocia', 'cesarean delivery', 'uterine monitoring'], 'conditions': ['Labor (Obstetrics)--Complications', 'Labor; Dyscoordinate']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nIn 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.\n\nAdditional data will be collected from the medical record to perform exploratory and hypothesis generating analysis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy pregnant women with a Singleton Term fetus in the Vertex position in labor.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age: 18-41 years at the due date\n* Term gestation: 37-41 weeks estimated gestational age (EGA)\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* Suspected fetal anomaly or intrauterine growth restriction: Any diagnosed fetal anomalies or intrauterine growth restriction as indicated in the health record.\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04251702', 'acronym': 'BUMP', 'briefTitle': 'Biomarkers of Uterine Muscle Physiology', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Two Novel Biomarkers for Labor Dystocia: Developing a Physiologic Understanding to Facilitate Precision in Diagnosis and Individualized Management', 'orgStudyIdInfo': {'id': '19-0307'}, 'secondaryIdInfos': [{'id': 'F31NR018582-01', 'link': 'https://reporter.nih.gov/quickSearch/F31NR018582-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Low-Risk Individuals in Labor', 'description': 'Healthy laboring individuals with a Singleton Term fetus in the Vertex position. Patients requiring medical management of diabetes or hypertension will be excluded.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jocelyn Phipers, MS', 'role': 'CONTACT', 'email': 'jocelyn.phipers@cuanschutz.edu'}], 'facility': 'UCHealth Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Katherine Kissler, PhD', 'role': 'CONTACT', 'email': 'katherine.kissler@cuanschutz.edu', 'phone': '303-724-4769'}], 'overallOfficials': [{'name': 'Katherine Kissler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Anschutz Medical Campus, College of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing can be arranged by contacting the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}, {'name': 'Nova Biomedical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}