Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-28 @ 10:23 AM
Study NCT ID:
NCT01385267
Status:
COMPLETED
Last Update Posted:
2018-12-28
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Lung Maturation in Twin Gestations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'A sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. Fetal lung maturity index and lamellar body count will be correlated to see if there is an association between Twin A and Twin B.\n\nFetal Lung Maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. Demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin A and B outcomes will be obtained through OB Traceview or patient chart.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-29', 'lastUpdatePostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FLM Index', 'timeFrame': '3 years', 'description': 'FLM Index'}, {'measure': 'Lamellar Body Counts', 'timeFrame': '3 years', 'description': 'Lamellar Body Counts'}], 'secondaryOutcomes': [{'measure': 'Respiratory Distress Syndrome', 'timeFrame': '3 years', 'description': 'Respiratory Distress Syndrome'}, {'measure': 'Transient Tachypnea in newborns', 'timeFrame': '3 years', 'description': 'Transient Tachypnea in newborns'}, {'measure': 'Neonatal Death', 'timeFrame': '3 years', 'description': 'Neonatal Death'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Discordance in Lung Maturity in Diamniotic Twins']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nTo evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.', 'detailedDescription': 'Objectives:\n\nTo evaluate discordance in lung maturity in diamniotic twins based on birth order, sex and body weight. If we find discordance in fetal lung maturity in twin gestations this will change current practice of sampling only one amniotic sac for evaluation of fetal lung maturity.\n\nHypotheses:\n\nLung maturation within twin pairs is weakly correlated based on presentation and estimated fetal weight.\n\nResearch Methods:\n\nThis study will be prospective cohort study of women with twin diamniotic intrauterine gestations who will be delivered at a Good Samaritan or Bethesda North Hospital. Patients will be counseled and informed consent for participation in the study will be obtained prior to enrollment in study.\n\nAt the time of Cesarean delivery or in the event of amniocenteses for FLM, a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count. Fetal lung maturity index and lamellar body count will be correlated to see if there is an association between Twin A and Twin B.\n\nFetal Lung Maturity index and lamellar body count will be calculated and compared based on fetal weight, sex, zigosity, and birth order. Demographic information, maternal obstetrical and medical history, newborn/fetal data, indications for cesarean section and twin A and B outcomes will be obtained through OB Traceview or patient chart.\n\nStudy population:\n\nParticipants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at Good Samaritan and Bethesda North Hospitals. Patients will be scheduled for a cesarean section by their primary MD prior to being approached for inclusion into the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will include pregnant patients, greater than 24 completed weeks with diamniotic twin gestations, at Good Samaritan and Bethesda North Hospitals. Patients will be scheduled for a cesarean section by their primary MD prior to being approached for inclusion into the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDiamniotic twin gestations\n\n* Twenty-four completed weeks gestation with dating calculated by their sure last menstrual period or utilizing a first trimester crown rump length ultrasound.\n* English Speaking\n* Scheduled cesarean section by patient's primary MD\n\nExclusion Criteria:\n\n* Monoamniotic twins\n* Presence of gross blood in amniotic sample\n* Presence of meconium amniotic fluid\n* Known/diagnosed fetal or newborn anomaly\n* Twin to Twin Transfusion Syndrome (TTTS)\n* Vaginal delivery"}, 'identificationModule': {'nctId': 'NCT01385267', 'briefTitle': 'Fetal Lung Maturation in Twin Gestations', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Fetal Lung Maturation in Twin Gestations Based on Birth Order and Weight Discordance', 'orgStudyIdInfo': {'id': '08074'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diamniotic twin gestations', 'interventionNames': ['Procedure: aspiration of amniotic fluid']}], 'interventions': [{'name': 'aspiration of amniotic fluid', 'type': 'PROCEDURE', 'otherNames': ['diamniotic twins'], 'description': 'a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count.', 'armGroupLabels': ['Diamniotic twin gestations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Donna Lambers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}