Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

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

— TIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975792
• Other study ID #: 817255
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: March 28, 2017
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Obstetric Labor, Premature
• Premature Birth
• Rupture
• Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Distress	Neonatal respiratory compromise defined as respiratory distress requiring any CPAP (continuous positive airway pressure) and or ventilator therapy.	Date of delivery up to 1 year