Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes

NCT ID: NCT01975792

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm Admits

Women who are admitted for preterm labor observation and management

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadav Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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817255

Identifier Type: -

Identifier Source: org_study_id

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