Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-27 @ 10:33 AM
Study NCT ID:
NCT01357369
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018962', 'term': 'Phlebotomy'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples for pharmacokinetics.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2011-05-18', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) results for Cefazolin and Ondansetron in maternal blood specimens', 'timeFrame': '10 hours', 'description': 'Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute.'}], 'secondaryOutcomes': [{'measure': 'Identification of placental transfer of studied meds (Cefazolin and Ondansetron)', 'timeFrame': '1 hr', 'description': 'By measuring the PK of the studied drugs in the umbilical cord sample we hope to gain information regarding placental transfer.\n\nPlasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute.'}, {'measure': 'PK results of neonatal blood specimens', 'timeFrame': '48 h', 'description': 'Plasma concentrations will be reported in mg/L. Plasma concentration will then be analyzed using nonlinear mixed effects modeling (nonmem) software to determine volume of distribution in L and clearance in L/minute.'}]}, 'conditionsModule': {'keywords': ['bacteria infections'], 'conditions': ['Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.', 'detailedDescription': 'There is very little data on drug metabolism during pregnancy, and how it may differ from the non-pregnant woman. There is even less data on placental transfer of drug to the neonate when medications are given prior to delivery. This study proposes to look at the pharmacokinetics of two drugs (Cefazolin and ondansetron) given routinely to pregnant women who are planning to deliver via cesarean section. The investigators will evaluate the metabolism of both drugs by the pregnant woman, the placental transfer over time, and the subsequent metabolism of the transferred drug in the neonate.\n\nThe investigators hope to learn 1) the pk profile of both drugs in pregnancy, and how it differs from the non-pregnant woman, 2) the placental transfer of both drugs, and 3) the profile of neonatal metabolism of the drug that crosses the placental barrier.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Generally health women at 37-42 weeks gestation, and their newborns.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult participant:\n\n* Age 18-45 years old\n* Term pregnancy (37-42 weeks)\n* Delivers by planned cesarean section, or unplanned, non-urgent cesarean section.\n* Generally healthy\n* Able and willing to sign informed consent\n\nNeonatal participant:\n\n* Male of female\n* 37-42 weeks gestation\n\nExclusion Criteria:\n\n* Adult:Medical condition that would effect metabolism of the study drugs\n* Known allergy to either study medication\n* Use of medications in the last 48 hours that might induce or inhibit metabolism of ondansetron (e.g. barbiturates, fluconazole, erythromycin, etc.)'}, 'identificationModule': {'nctId': 'NCT01357369', 'briefTitle': 'Study of Drug Concentration of Ondansetron and Cefazolin in Mothers and Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pharmacokinetics and Placental Transfer of Ondansetron and Cefazolin: A Preliminary Analysis', 'orgStudyIdInfo': {'id': 'SU-02252011-7482'}, 'secondaryIdInfos': [{'id': 'IRB 20231'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ondansetron/Cefazolin treatment', 'description': 'Pregnant women undergoing uncomplicated cesarean section deliveries who have consented to participate, and will receive Ondansetron and Cefazolin in the course of their clinical care will have PK blood samples drawn.', 'interventionNames': ['Procedure: Phlebotomy']}], 'interventions': [{'name': 'Phlebotomy', 'type': 'PROCEDURE', 'description': 'Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.', 'armGroupLabels': ['Ondansetron/Cefazolin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Brendan Carvalho', 'role': 'SUB_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'David R. Drover', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David R. Drover', 'investigatorAffiliation': 'Stanford University'}}}}