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Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

Completed
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
Inclusion Criteria
  • Singleton pregnancy between 28-36 weeks gestation
  • Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)
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Exclusion Criteria
  • Non-singleton pregnancies
  • Gestational hypertension/preeclampsia
  • Major fetal anomalies
  • Known fetal aneuploidy
  • Intrauterine Fetal Demise
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Respiratory DistressDate 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
NameTimeMethod

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

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