Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT03567551
Status:
COMPLETED
Last Update Posted:
2022-01-21
First Post:
2018-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aquaporin 4 protein fragments in maternal blood plasma', 'timeFrame': 'Between hospital admission and prior to epidural or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}, {'measure': 'S100B protein fragments in maternal blood plasma', 'timeFrame': 'Between hospital admission and prior to epidural or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence'}, {'measure': 'Aquaporin 4 protein fragments in cerebrospinal fluid', 'timeFrame': 'At the time of spinal or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}, {'measure': 'S100B protein fragments in cerebrospinal fluid', 'timeFrame': 'At the time of spinal or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}, {'measure': 'Aquaporin 4 protein fragments in cord blood and placental samples', 'timeFrame': 'Between delivery and 2 hours after delivery', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}, {'measure': 'S100B protein fragments in cord blood and placental samples', 'timeFrame': 'Between delivery and 2 hours after delivery', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}], 'secondaryOutcomes': [{'measure': 'Fatty acids in maternal blood', 'timeFrame': 'Between hospital admission and prior to epidural or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence'}, {'measure': 'Fatty acids in cord blood and placental samples', 'timeFrame': 'Between immediately post-delivery and 2 hours after delivery', 'description': 'The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence'}, {'measure': 'Fatty Acids in cerebrospinal fluid', 'timeFrame': 'during epidural or combined spinal/epidural anesthesia', 'description': 'The investigators plan to perform targeted testing for markers that The investigators predict based on their findings or based on available published evidence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'Pregnancy', 'Complications', 'Eclampsia', 'Aquaporin', 'Aquaporin 4'], 'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'This is a research study designed to help identify preeclampsia in pregnant women earlier, and possibly lead to better treatment for women preeclampsia.', 'detailedDescription': 'There is a paucity of biomarkers to predict preeclampsia and for predicting the severity of preeclampsia. This study was designed to identify novel biomarkers for both the prediction of preeclampsia in previously normal pregnancies and for the prediction of the severity of preeclampsia in preeclamptic women. The investigators plan to perform targeted testing for markers that the investigators predict based on their findings or based on available published evidence and the investigators also plan testing for novel markers using various approaches such as proteomics, lipidomics and genomics. The targeted markers will include Aquaporin 4 (AQP4), soluble aquaporin fragments, chemokines, and halogenated fatty acids in the plasma and/or spinal fluid. Aquaporin fragments and AQP4 have been hypothesized to correlate with severe headaches which are complications of severe preeclampsia. The investigators found in their murine studies that there is a correlation between the presence of halogenated fatty acids in the plasma and elevated blood pressure in a murine model of preeclampsia. The approaches will complement the targeted analyses to identify novel markers that have not been predicted yet.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women older than 20 years of age, who meet all inclusion criteria and none of the exclusion criteria, and who are willing and able to sign informed consent documentation, as well as receive a combined spinal/epidural, or a spinal anesthesia regimen.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Greater than or equal to 20 years of age\n* Greater than 24 weeks of gestation\n* Obstetrics/Anesthesia Team had decided that Combined Spinal/Epidural (CSE) or Spinal Anesthesia will be performed\n\nExclusion Criteria:\n\n* Pre-pregnancy comorbidities:\n* hypertension, diabetes, or pulmonary hypertension\n* use of steroids, beta blockers, Ca channel antagonist, anticoagulants\n* cardiac or vascular conditions\n* severe headaches or visual disturbances\n* Inability to receive CSE or Spinal Anesthesia\n* Chorioamnionitis, fever, bronchitis, pneumonia'}, 'identificationModule': {'nctId': 'NCT03567551', 'briefTitle': 'Novel Biomarkers of Preeclampsia, Aquaporin, Fatty Acid, and S110B', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Novel Biomarkers of Preeclampsia: Aquaporin, Fatty Acid, and S100B', 'orgStudyIdInfo': {'id': 'IRB-160822006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women w/ Preeclampsia w/o Visual Disturbances or Headache', 'description': 'Preeclampsia Without either Visual Disturbances or Headaches Blood Pressure: \\>Systolic 160 or Diastolic 110', 'interventionNames': ['Other: Women w/ Preeclampsia w/o Visual Disturbances or Headache']}, {'label': 'Women w/ Preeclampsia w/ Visual Disturbances or Headaches', 'description': 'Preeclampsia With either Visual Disturbances or Headaches Blood Pressure: \\>Systolic 160 or Diastolic 110', 'interventionNames': ['Other: Women w/ Preeclampsia w/ Visual Disturbances or Headaches']}, {'label': 'Women w/o Preeclampsia', 'description': 'Normal Pregnancy Blood Pressure: \\<140/90', 'interventionNames': ['Other: Women w/o Preeclampsia']}], 'interventions': [{'name': 'Women w/ Preeclampsia w/o Visual Disturbances or Headache', 'type': 'OTHER', 'description': 'Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant', 'armGroupLabels': ['Women w/ Preeclampsia w/o Visual Disturbances or Headache']}, {'name': 'Women w/ Preeclampsia w/ Visual Disturbances or Headaches', 'type': 'OTHER', 'description': 'Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant', 'armGroupLabels': ['Women w/ Preeclampsia w/ Visual Disturbances or Headaches']}, {'name': 'Women w/o Preeclampsia', 'type': 'OTHER', 'description': 'Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant', 'armGroupLabels': ['Women w/o Preeclampsia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Tekuila Carter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tekuila Carter', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}