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Completed

NCT Number: NCT01975792

Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton pregnancy between 28-36 weeks gestation
  • Active spontaneous preterm labor symptoms (contractions, cervical dilatation and/or PPROM)

Exclusion criteria

  • Non-singleton pregnancies
  • Gestational hypertension/preeclampsia
  • Major fetal anomalies
  • Known fetal aneuploidy
  • Intrauterine Fetal Demise

Treatment and study plan

Primary outcomes

  1. Respiratory Distress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcome in Women at High Risk for Preterm Delivery

Acronym: TIPS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2013
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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