Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-28 @ 2:29 PM
Study NCT ID:
NCT01985594
Status:
UNKNOWN
Last Update Posted:
2013-11-15
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
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': 'C000624167', 'term': 'Utrogestan'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-10', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2013-11-10', 'lastUpdatePostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'latency period interval between time of tocolysis and delivery', 'timeFrame': '24 hours up to 7 days', 'description': 'delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis'}], 'secondaryOutcomes': [{'measure': 'Pregnancy outcomes', 'timeFrame': '34 weeks of gestational age', 'description': 'delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation'}, {'measure': 'Neonatal outcome', 'timeFrame': '24 hours', 'description': 'Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission'}, {'measure': 'Maternal side effect', 'timeFrame': '30 minutes up to 48 hours', 'description': 'Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['preterm labor'], '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.'}]}, 'descriptionModule': {'briefSummary': 'RESEARCH HYPOTHESIS\n\n-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.\n\nExclusion Criteria:\n\n* Multiple pregnancies\n* Women with Preterm Prelabour Rupture of Membrane\n* Fetal death\n* Women with bad obstetric history\n* Women with history of cervical incompetence\n* Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan\n* Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta\n* Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage\n* Cervical dilatation of 3cm or more\n* Patients with previous tocolytic treatment during this pregnancy\n* Women who refuse to participate in this study'}, 'identificationModule': {'nctId': 'NCT01985594', 'acronym': 'UTROGESTAN', 'briefTitle': 'Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR', 'orgStudyIdInfo': {'id': 'FF-2013-407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Utrogestan', 'description': 'oral tablet Utrogestan 400mg daily for 2 days', 'interventionNames': ['Drug: utrogestan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nifedipine', 'description': 'tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days', 'interventionNames': ['Drug: Nifedipine']}], 'interventions': [{'name': 'utrogestan', 'type': 'DRUG', 'description': 'Oral Tablet Utrogestan 400 mg daily for 2 days', 'armGroupLabels': ['Utrogestan']}, {'name': 'Nifedipine', 'type': 'DRUG', 'description': 'Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days', 'armGroupLabels': ['Nifedipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Cheras', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'contacts': [{'name': 'national university of malaysia medical centre', 'role': 'CONTACT', 'phone': '60391455950'}, {'name': 'nor zila hassan malek', 'role': 'SUB_INVESTIGATOR'}, {'name': 'nor azlin mohamed ismail', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Obstetric and Gynaecology Department, National University of Malaysia Medical Centre'}], 'centralContacts': [{'name': 'nor zila hassan malek', 'role': 'CONTACT', 'email': 'nzhm_dr@yahoo.com', 'phone': '60139823219'}], 'overallOfficials': [{'name': 'nor azlin mohamed ismail', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Malaysia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nor zila hassan malek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'medical officer', 'investigatorFullName': 'nor zila hassan malek', 'investigatorAffiliation': 'National University of Malaysia'}}}}