Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes
- Conditions
- Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)
- Registration Number
- NCT01975792
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 125
- Singleton pregnancy between 28-36 weeks gestation
- Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)
- Non-singleton pregnancies
- Gestational hypertension/preeclampsia
- Major fetal anomalies
- Known fetal aneuploidy
- Intrauterine Fetal Demise
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Respiratory Distress Date of delivery up to 1 year Neonatal respiratory compromise defined as respiratory distress requiring any CPAP (continuous positive airway pressure) and or ventilator therapy.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States