Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00901758
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2009-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous (IV) Nitroglycerin for Versions in Multiparous Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001946', 'term': 'Breech Presentation'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2009-05-13', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of ECV (if fetus turned from Breech to cephalic) at end of ECV procedure', 'timeFrame': 'Recorded at the end of ECV attempt'}], 'secondaryOutcomes': [{'measure': 'Success of ECV (ie fetus in cephalic presentation) recorded at time of delivery', 'timeFrame': 'Recorded at time of birth'}, {'measure': 'Mode of delivery', 'timeFrame': 'Recorded at time of birth'}, {'measure': 'Maternal side effects and adverse events', 'timeFrame': "Recorded until date of birth (up to 3 weeks' duration)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breech Presentation', 'Pregnancy Complication']}, 'referencesModule': {'references': [{'pmid': '19701035', 'type': 'RESULT', 'citation': 'Hilton J, Allan B, Swaby C, Wah R, Jarrell J, Wood S, Ross S, Tran Q. Intravenous nitroglycerin for external cephalic version: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):560-567. doi: 10.1097/AOG.0b013e3181b05a19.'}]}, 'descriptionModule': {'briefSummary': 'Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV).\n\nDrugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials.\n\nThis study is designed to answer the following questions for multiparous women:\n\nWill administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any non-cephalic presentation\n* singleton pregnancy\n* \\>/= 37 weeks gestational age\n* normal amniotic fluid volume\n* reassuring fetal heart rate\n\nExclusion Criteria:\n\n* labor\n* ruptured membranes\n* history of third trimester bleeding\n* any pre-existing uterine scar\n* pregnancy induced hypertension and gestational diabetes\n* oligohydramnios and polyhydramnios\n* intrauterine growth restriction or macrosomia\n* hypotension or any serious medical illness\n* inability to comprehend consent form'}, 'identificationModule': {'nctId': 'NCT00901758', 'acronym': 'INVERT (02)', 'briefTitle': 'Intravenous (IV) Nitroglycerin for Versions in Multiparous Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Intravenous (IV) Nitroglycerin for Versions in Multiparous Women', 'orgStudyIdInfo': {'id': 'INVERT-02'}, 'secondaryIdInfos': [{'id': 'CHREB #16682'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo solution was normal saline. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL.', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Treatment solution consisted of 100micrograms/mL of nitroglycerin. After an initial 1mL dose, further doses could be given in 1-3mL increments until uterine relaxation was achieved, or up to a recommended maximum of 10mL.', 'interventionNames': ['Drug: IV Nitroglycerin']}], 'interventions': [{'name': 'IV Nitroglycerin', 'type': 'DRUG', 'description': 'IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL.', 'armGroupLabels': ['1']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'IV injection, initial does of 1mL, with further doses of 1-3mL, up to a recommended maximum of 10mL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4J8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Peter Lougheed Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Rockyview Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Bruce B Allan, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Calgary Health Region'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr B Allan', 'oldOrganization': 'Department of Obstetrics and Gynecology, Rockyview General Hospital'}}}}