Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01975792

Acronym

TIPS

Enrollment

125

Registered

2013-11-05

Start date

2013-03-31

Completion date

2014-04-30

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

Keywords

PPROM, Pregnant, Preterm, Premature, labor

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results