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

University of Pennsylvania

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

Funder types: Other

Identifiers

NCT01975792

817255

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

125 participants in 1 patient group

Preterm Admits

Description:

Women who are admitted for preterm labor observation and management