Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-03-02 @ 6:24 PM
Study NCT ID:
NCT02132533
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nifedipine for Acute Tocolysis of Preterm Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dawn.wilson@utsouthwestern.edu', 'phone': '214-648-2316', 'title': 'Chet Edward Wells, MD', 'organization': 'UT Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Less than 37 weeks of gestation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 48 hours of randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At least 2 doses of betamethasone administered prior to delivery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Preterm Birth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days of randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.\n\nNifedipine: Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Women with preterm labor will receive placebo.\n\nPlacebo: Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.\n\nUsual care: Usual evaluation, monitoring and care for women with preterm labor.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '26.7', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-22', 'size': 570698, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-07T15:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-17', 'studyFirstSubmitDate': '2014-04-30', 'resultsFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-07', 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Preterm Birth', 'timeFrame': 'Less than 37 weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Preterm Birth', 'timeFrame': 'Within 48 hours of randomization'}, {'measure': 'Number of Participants With Preterm Birth', 'timeFrame': 'At least 2 doses of betamethasone administered prior to delivery'}, {'measure': 'Number of Participants With Preterm Birth', 'timeFrame': 'Within 7 days of randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Labor']}, '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.'}, {'pmid': '34259466', 'type': 'DERIVED', 'citation': 'Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 16 and 44 years of age inclusive\n* Singleton pregnancy\n* Intact membranes\n* Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive\n* Reported or documented uterine activity\n* Cervical dilation between 2 cm and 4 cm inclusive\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Less than 28 weeks' gestation\n* 34 or more weeks' gestation\n* Ruptured membranes\n* More than 4 cm dilated\n* Previously received a course of corticosteroids for fetal lung maturation\n* Oligohydramnios\n* Fetal growth restriction\n* Chorioamnionitis or temperature of at least 38.0 degrees Celsius\n* Fetal death\n* Preeclampsia\n* Suspected placental abruption or placenta previa\n* Lethal fetal malformation or amniotic fluid index at least 35\n* Systolic BP \\< 90 mmHg or diastolic BP \\< 50 mmHg\n* Baseline tachycardia (pulse \\>120 after 2 consecutive measurements 30 minutes apart)\n* Chronic hypertension treated with antihypertensives in pregnancy\n* Seizure disorder or HIV\n* Maternal allergy to nifedipine\n* Known maternal cardiac disease\n* Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth"}, 'identificationModule': {'nctId': 'NCT02132533', 'acronym': 'Nifedipine', 'briefTitle': 'Nifedipine for Acute Tocolysis of Preterm Labor', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Nifedipine for Acute Tocolysis of Preterm Labor', 'orgStudyIdInfo': {'id': '122013-063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nifedipine', 'description': 'Women with preterm labor will receive nifedipine.', 'interventionNames': ['Drug: Nifedipine', 'Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Women with preterm labor will receive placebo.', 'interventionNames': ['Drug: Placebo', 'Other: Usual care']}], 'interventions': [{'name': 'Nifedipine', 'type': 'DRUG', 'description': 'Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.', 'armGroupLabels': ['Nifedipine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.', 'armGroupLabels': ['Placebo']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual evaluation, monitoring and care for women with preterm labor.', 'armGroupLabels': ['Nifedipine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Brian M Casey, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Alabama Medical Center, Birmingham, AL'}, {'name': 'Donald D McIntire, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Kenneth J Leveno, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Chet E Wells, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Josiah S Hawkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Medical Center, Oakland, CA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}