Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

NCT01975792 | Completed

• 1 other identifier: 817255
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Preterm Admits

Women who are admitted for preterm labor observation and management

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Premature Birth; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nadav Schwartz, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: November 5, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)