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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01975792
First received: September 4, 2013
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcome in Women at High Risk for Preterm Delivery

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Respiratory Distress [ Time Frame: Date of delivery up to 1 year ] [ Designated as safety issue: No ]
    Neonatal respiratory compromise defined as respiratory distress requiring any CPAP (continuous positive airway pressure) and or ventilator therapy.


Enrollment: 125
Study Start Date: March 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm Admits
Women who are admitted for preterm labor observation and management

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975792

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Nadav Schwartz, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01975792     History of Changes
Other Study ID Numbers: 817255 
Study First Received: September 4, 2013
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
PPROM
Pregnant
Preterm
Premature, labor

Additional relevant MeSH terms:
Premature Birth
Rupture
Obstetric Labor, Premature
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2016