Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes (TIPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19106
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with singleton pregnancies admitted to labor and delivery at the Hospital of the University of Pennsylvania between 28-36 weeks gestation for the management of spontaneous preterm labor (defined as uterine contractions and documented cervical change) and/or preterm premature rupture of membranes.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Preterm Admits; Women who are admitted for preterm labor observation and management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Nadav Schwartz, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 5, 2013

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Preterm; PPROM; Pregnant; Premature, labor
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Rupture; Premature Birth; Obstetric Labor, Premature; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 817255