Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT06900257
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-18
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Cardiac Functions in Fasting Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Singleton uncomplicated pregnancies with at least 10 days of fasting.', 'timeFrame': 'Fetal echocardiographic findings after at least 10 days of fasting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fasting', 'Pregnancy', 'Fetal echocardiography', 'Fetal health'], 'conditions': ['Fasting Pregnant Women']}, 'descriptionModule': {'briefSummary': 'In this study, we aimed to evaluate fetal cardiac functions after a fasting period of at least 10 days. The purpose of this study was to determine the unexpected effects of fasting on fetal cardiac functions.', 'detailedDescription': 'Pregnancies at 24-34 weeks of gestation who present to our hospital for routine antenatal follow-up will be evaluated. As the study group, singleton uncomplicated pregnancies with at least 10 days of fasting will be assessed. All ultrasonographic examinations will be conducted within the last 2 hours of the fasting period. The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicated pregnancies between 24-34 weeks, matched for age, parity, and gestational age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Singleton uncomplicated pregnancies that present for routine antenatal follow-up between 24-34 weeks of gestation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton, uncomplicated pregnancies that have been fasting for at least the last 10 days\n* Present for routine antenatal follow-up between 24-34 weeks of gestation\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Premature rupture of membranes\n* Chorioamnionitis\n* Placental abruption\n* Severe fetal growth restriction\n* Congenital fetal anomalies\n* Preeclampsia\n* Oligohydramnios\n* Maternal diabetes -Conditions where fasting is contraindicated for the mother. -'}, 'identificationModule': {'nctId': 'NCT06900257', 'briefTitle': 'Fetal Cardiac Functions in Fasting Pregnant Women', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanliurfa Education and Research Hospital'}, 'officialTitle': 'Evaluation of Fetal Cardiac Functions in Fasting Pregnant Women', 'orgStudyIdInfo': {'id': 'ŞEAH/fasting card'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Singleton uncomplicated pregnancies with at least 10 days of fasting.', 'interventionNames': ['Procedure: Pregnant women who present for routine antenatal follow-up between 24-34 weeks of gestation.']}, {'label': 'The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicat', 'interventionNames': ['Procedure: Pregnant women who present for routine antenatal follow-up between 24-34 weeks of gestation.']}], 'interventions': [{'name': 'Pregnant women who present for routine antenatal follow-up between 24-34 weeks of gestation.', 'type': 'PROCEDURE', 'description': 'All singleton uncomplicated pregnancies that present to our hospital for routine antenatal follow-up between 24-34 weeks of gestation will be included in this study.', 'armGroupLabels': ['Singleton uncomplicated pregnancies with at least 10 days of fasting.', 'The control group will consist of healthy pregnant women who do not fast, with singleton uncomplicat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Sanliurfa', 'country': 'Turkey (Türkiye)', 'facility': 'Sanliurfa Education 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'}}}}