Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-04 @ 3:18 PM
Study NCT ID:
NCT02332304
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2015-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-04', 'studyFirstSubmitDate': '2015-01-04', 'studyFirstSubmitQcDate': '2015-01-04', 'lastUpdatePostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Distress Syndrome, Newborn', 'timeFrame': '1 month', 'description': 'Diagnosis of Respiratory Distress Syndrome in the neonatal period. The diagnosis was made by the neonatologist in charge (using clinical and radiological parameters).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Distress Syndrome, Newborn'], 'conditions': ['Respiratory Distress Syndrome, Newborn']}, 'descriptionModule': {'briefSummary': 'To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy between 26 and 36 6/7 weeks.\n\nExclusion Criteria:\n\n* Problems in the handling of the amniotic fluid sample that prevented the calculation of the optical density.'}, 'identificationModule': {'nctId': 'NCT02332304', 'briefTitle': 'Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Amniotic Fluid Optical Density Determination Between 28 and 36 6/7 Weeks of Pregnancy and Its Relationship With the Diagnosis of Neonatal Respiratory Distress Syndrome.', 'orgStudyIdInfo': {'id': 'MHST2014-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Preterm fetus', 'description': 'Patients with pregnancies between 26 and 36 6/7 weeks of pregnancy. Before the birth, a sample of amniotic fluid was taken and analyzed using optical density at 650nm. A value above 0.15 was considered an indication of fetal lung maturity.', 'interventionNames': ['Procedure: Preterm fetus']}], 'interventions': [{'name': 'Preterm fetus', 'type': 'PROCEDURE', 'description': 'A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.', 'armGroupLabels': ['Preterm fetus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'country': 'Panama', 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Osvaldo Reyes, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saint Thomas Hospital, Panama'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Research', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}