Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT00385294
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2006-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of B2 Adrenergic Receptors in Labor Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA identified by subject number will be retained for analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2006-10-05', 'studyFirstSubmitQcDate': '2006-10-05', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Genetic', 'pain', 'obstetrical'], 'conditions': ['Pain', 'Pain Threshold', 'Labour Pain']}, 'referencesModule': {'references': [{'pmid': '16645459', 'type': 'BACKGROUND', 'citation': 'Liang DY, Liao G, Wang J, Usuka J, Guo Y, Peltz G, Clark JD. A genetic analysis of opioid-induced hyperalgesia in mice. Anesthesiology. 2006 May;104(5):1054-62. doi: 10.1097/00000542-200605000-00023.'}, {'pmid': '16129988', 'type': 'BACKGROUND', 'citation': 'Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.'}]}, 'descriptionModule': {'briefSummary': "The study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.", 'detailedDescription': 'Other than parity, and infant size, the etiology of the great variability in labor pain us unknown. Previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is related to pain in labor. The study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. The investigators will determine whether B2 receptor haplotype is an independent predictor of pain experienced in labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nuliparous women anticipating NSVD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nulliparous women\n* Third trimester of pregnancy on enrollment\n\nExclusion Criteria:\n\n* Chronic Pain\n* Pain medication utilization\n* Large for gestational age baby\n* Small for gestational age baby\n* Systemic illness'}, 'identificationModule': {'nctId': 'NCT00385294', 'briefTitle': 'Role of B2 Adrenergic Receptors in Labor Pain', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Role of B2 Adrenergic Receptors in Labor Pain', 'orgStudyIdInfo': {'id': 'AAAB3535'}}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pamela D. Flood, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Pamela Flood', 'investigatorAffiliation': 'Columbia University'}}}}