Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT01211912
Status:
COMPLETED
Last Update Posted:
2014-09-01
First Post:
2010-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-29', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal and neonatal serum acetaminophen level', 'timeFrame': 'Time Frame: 30 minutes to 24 hours post administration', 'description': 'Pregnant women will be given 1000 mg of acetaminophen orally and have both maternal and neonatal serum acetaminophen levels checked at the time of cesarean section 30 minutes to 24 hours after administration.'}, {'measure': 'Fetal breathing and body movements', 'timeFrame': 'Time Frame: 60 minutes', 'description': 'Pregnant women will have a baseline assessment of fetal breathing and body movements with ultrasound and will then be given 1000 mg of acetaminophen orally. Fetal breathing and body movements will then be reassessed 60 minutes later.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fetal movement', 'Fetal breathing', 'Acetaminophen'], 'conditions': ['Fetal Testing', 'Transplacental Transfer of Acetaminophen']}, 'descriptionModule': {'briefSummary': 'This study has two aims:\n\n1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)\n2. to understand the impact of maternal acetaminophen use on fetal movement and breathing (20 patients)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Pregnant females\n* Age 18-44\n* Any race\n* Any parity\n* Singleton Gestations\n* Weight between 60-90 kg\n\nExclusion Criteria\n\n* Acetaminophen Allergy\n* Contraindication to Acetaminophen Use\n* Chorioamnionitis\n* Preeclampsia\n* Diabetes Mellitus\n* Placental Abruption\n* Placenta Previa\n* Fetal Anomaly\n* Intrauterine growth restriction (IUGR)\n* Multiple Gestations\n* Maternal Medical Disease\n* Acetaminophen use in the last 3 days\n* Plan to donate or bank fetal cord blood'}, 'identificationModule': {'nctId': 'NCT01211912', 'briefTitle': 'Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being', 'orgStudyIdInfo': {'id': '10-003283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (20 patients)', 'description': 'Pregnant women will be given a single dose of 1000 mg of acetaminophen orally after a baseline ultrasound and 60 minutes before a repeat ultrasound.', 'interventionNames': ['Drug: Arm 1 (20 patients)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (34 patients)', 'description': 'Pregnant women will be given a single dose of 1000 mg of acetaminophen orally 30 minutes to 24 hours before a scheduled cesarean section.', 'interventionNames': ['Drug: Arm 2 (34 patients)']}], 'interventions': [{'name': 'Arm 1 (20 patients)', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Acetaminophen 1000 mg by mouth once', 'armGroupLabels': ['Arm 1 (20 patients)']}, {'name': 'Arm 2 (34 patients)', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Acetaminophen 1000 mg by mouth once', 'armGroupLabels': ['Arm 2 (34 patients)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Brian C Brost, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Brian C. Brost, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}