Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 4:41 AM
Study NCT ID:
NCT01360034
Status:
UNKNOWN
Last Update Posted:
2015-01-05
First Post:
2011-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D007213', 'term': 'Indomethacin'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-01', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Reduction of preterm labour (before 35 weeks).', 'timeFrame': '48 months'}, {'measure': 'Adverse effects', 'timeFrame': '48 months', 'description': 'To determine the frequency of maternal adverse effects related to the use of both drugs (nifedipine and indomethacin). These include the development of any type of rash, nausea, weakness/hypotension, headache, dyspepsy or bleeding disorders of any kind.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstetric labor, premature', 'Short cervix', 'Nifedipine', 'Indomethacin'], 'conditions': ['Obstetric Labor, Premature']}, 'referencesModule': {'references': [{'pmid': '35947046', 'type': 'DERIVED', 'citation': 'Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (\\< 2.5cms).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between 24 and 34 weeks of gestation.\n* Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less\n\nExclusion Criteria:\n\n* All contraindications for tocolysis (fetal distress, abruptio placenta).\n* Multiple pregnancy.\n* All contraindications for the use of any of the two drugs (indomethacin or nifedipine).'}, 'identificationModule': {'nctId': 'NCT01360034', 'briefTitle': 'Nifedipine Versus Indomethacin in the Treatment of Preterm Labour', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': 'MHST2011-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nifedipine', 'description': '108 patients will receive nifedipine as tocolytic for 48 hours.', 'interventionNames': ['Drug: Nifedipine']}, {'type': 'EXPERIMENTAL', 'label': 'Indomethacin', 'description': '108 patients will receive indomethacin as tocolytic for 48 hours.', 'interventionNames': ['Drug: Indomethacin']}], 'interventions': [{'name': 'Nifedipine', 'type': 'DRUG', 'description': 'Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.', 'armGroupLabels': ['Nifedipine']}, {'name': 'Indomethacin', 'type': 'DRUG', 'description': 'Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.', 'armGroupLabels': ['Indomethacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'centralContacts': [{'name': 'Jorge Espinosa, Resident', 'role': 'CONTACT', 'email': 'bobbyone-79@hotmail.com'}, {'name': 'Osvaldo Reyes, MD', 'role': 'CONTACT', 'email': 'oreyespanama@yahoo.es'}], 'overallOfficials': [{'name': 'Jorge Espinosa, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Hospital, Panama'}, {'name': 'Osvaldo Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}