Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 11:35 AM
Study NCT ID:
NCT06904534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of nifedipine or MgSO4 as tocolytic agents', 'timeFrame': 'Fetal echocardiographic findings after 48 hours the use of nifedipine or MgSO4', 'description': 'Pregnancies between 24-34 weeks of gestation using nifedipine and MgSO4 for tocolysis will be evaluated. Preterm labor is defined as persistent uterine contractions (at least two contractions every 10 minutes or four contractions in 1 hour) resulting in cervical changes (at least 80% effacement and 2 cm cervical dilation). Nifedipine will be administered as an initial 10 mg oral loading dose every 20 minutes for one hour, followed by 10 mg oral maintenance doses every 6 hours for 48 hours. The MgSO4 treatment protocol involves a 100 mL infusion of 5% dextrose containing 4-6 grams of MgSO4 (MgSO4 15% amp.) as an intravenous (IV) loading dose over 20 minutes, followed by a maintenance dose of 2 grams per hour IV. During treatment, patients will be monitored hourly for urination patterns, deep tendon reflexes, and respiratory rate. Treatment will be stopped 6 hours after the cessation of contractions. Doppler measurements will be taken before the first treatment dose and 48 hours after.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nifedipine', 'MgSO4', 'Fetal echocardiography.'], 'conditions': ['Unexpected Fetal Cardiac Effects of Nifedipine and MgSO4']}, 'descriptionModule': {'briefSummary': 'The potential unexpected effects of nifedipine and MgSO4, the tocolytic agents used for the indication of preterm labor, on fetal heart will be determined. In this study, the fetal echocardiographic findings of nifedipine and MgSO4 will be compared.', 'detailedDescription': 'This study will include pregnancies at 24-34 weeks of gestation that are using nifedipine and MgSO4 for tocolysis. Fetal echocardiographic findings of these pregnancies will be recorded'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with preterm labor indication at 24-34 weeks of gestation who are treated with nifedipine or MgSO4 for tocolysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:-Patients with preterm labor indication at 24-34 weeks of gestation\n\n-Treated with nifedipine or MgSO4 for tocolysis\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* premature rupture of membranes\n* Chorioamnionitis\n* Placental abruption\n* Severe fetal growth restriction\n* Congenital anomalies of the fetus\n* Preeclampsia\n* Oligohydramnios\n* Maternal diabetes\n* Contraindications for the use of nifedipine and/or MgSO4 in the mother'}, 'identificationModule': {'nctId': 'NCT06904534', 'briefTitle': 'Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanliurfa Education and Research Hospital'}, 'officialTitle': 'Comparison of Fetal Cardiac Functions in Pregnant Women Using Nifedipine and Magnesium Sulfate for Tocolysis', 'orgStudyIdInfo': {'id': 'SEAH-CARD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnancies using nifedipine and MgSO4 for tocolytic purposes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Şanlıurfa Training and Research Hospital', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanliurfa Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}