Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-26 @ 11:05 AM
Study NCT ID:
NCT01975792
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2013-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2013-09-04', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Distress', 'timeFrame': 'Date of delivery up to 1 year', 'description': 'Neonatal respiratory compromise defined as respiratory distress requiring any CPAP (continuous positive airway pressure) and or ventilator therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PPROM', 'Pregnant', 'Preterm', 'Premature, labor'], 'conditions': ['Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)']}, 'descriptionModule': {'briefSummary': 'The thymus gland is a specialized organ in the chest that plays a central role in the adaptive immune system throughout development until puberty. In response to stress, the fetal thymus gland may shrink, or involute. The investigators propose a prospective cohort study that will enroll pregnant women admitted to labor and delivery for the management of preterm labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on sonographic thymus measurements, the investigators will develop a clinical prediction tool to identify babies who are at increased risk for adverse neonatal outcomes. A reliable non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has the potential to affect clinical management, improve outcomes for premature babies, and direct further research efforts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients with singleton pregnancies admitted to labor and delivery at the Hospital of the University of Pennsylvania between 28-36 weeks gestation for the management of spontaneous preterm labor (defined as uterine contractions and documented cervical change) and/or preterm premature rupture of membranes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy between 28-36 weeks gestation\n* Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)\n\nExclusion Criteria:\n\n* Non-singleton pregnancies\n* Gestational hypertension/preeclampsia\n* Major fetal anomalies\n* Known fetal aneuploidy\n* Intrauterine Fetal Demise'}, 'identificationModule': {'nctId': 'NCT01975792', 'acronym': 'TIPS', 'briefTitle': 'Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcome in Women at High Risk for Preterm Delivery', 'orgStudyIdInfo': {'id': '817255'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm Admits', 'description': 'Women who are admitted for preterm labor observation and management'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Nadav Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}