Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:38 AM
Study NCT ID:
NCT07493720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011258', 'term': 'Pregnancy Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beta-hCG value', 'timeFrame': 'Once on date of enrollment', 'description': 'Venipuncture and peripheral finger stick serum will be tested for beta-hCG levels.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['pregnancy'], 'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '21875776', 'type': 'RESULT', 'citation': 'Fromm C, Likourezos A, Haines L, Khan AN, Williams J, Berezow J. Substituting whole blood for urine in a bedside pregnancy test. J Emerg Med. 2012 Sep;43(3):478-82. doi: 10.1016/j.jemermed.2011.05.028. Epub 2011 Aug 27.'}]}, 'descriptionModule': {'briefSummary': "The objective of his study is to quantitatively evaluate a patient's pregnancy status using their beta-hCG levels when using venipuncture blood vs peripheral blood.", 'detailedDescription': "The objective of his study is to quantitatively evaluate a patient's pregnancy status using their beta-hCG levels when using venipuncture blood vs peripheral blood. This data will help the investigator compare trending levels of beta-hCG levels in pregnant patients between venous blood vs peripheral blood which may help determine levels at which the peripheral blood may no longer be detectable on a POC pregnancy test."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '19 years of age, positive pregnant status recorded in EMR, presenting to Nebraska Medicine OB/GYN clinic', 'genderDescription': 'Biological female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: 19 years of age, positive pregnant status recorded in EMR, presenting to Nebraska Medicine OB/GYN clinic -\n\nExclusion Criteria: No meeting the inclusion criteria\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07493720', 'acronym': 'P-Beta-H', 'briefTitle': 'Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Comparison of Beta-hCG Levels When Using Venous Puncture Blood and Peripheral Finger Stick Blood', 'orgStudyIdInfo': {'id': '0843-25-EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '19 years of age or older, positive pregnancy status', 'interventionNames': ['Diagnostic Test: Beta-hCG']}], 'interventions': [{'name': 'Beta-hCG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Enrolled participants will provide 2 serum specimens (venipuncture and peripheral finger stick) for beta-hCG testing', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-1150', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'contacts': [{'name': 'Thanh Nguyen', 'role': 'CONTACT', 'email': 'thang.nguyen@unmc.edu', 'phone': '4025597884'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Thanh Nguyen, PhD', 'role': 'CONTACT', 'email': 'thang.nguyen@unmc.edu', 'phone': '14025597884'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Thanh Nguyen', 'investigatorAffiliation': 'University of Nebraska'}}}}