NCT02996279

Brief Summary

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS) and increased levels of proinflammatory molecules.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

November 25, 2016

Last Update Submit

December 14, 2016

Conditions

Chorioamnionitis Affecting Fetus or Newborn

Keywords

NeonateChorioamnionitisS100A12

Outcome Measures

Primary Outcomes (1)

  • S100A12 in Presence of Maternal Chorioamnionitis

    Levels of S100A12 in Maternal, Cord and Neonatal Blood in the Presence or Absence of HCA

    1 Year

Study Arms (2)

group 1

maternal chorioamnionitis

group 2

no maternal chorioamnionitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Very Premature Mother-Neonate Pairs

You may qualify if:

  • Preterm Birth

You may not qualify if:

  • Congenital Abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

MATERNAL, CORD AND NEONATAL BLOOD

MeSH Terms

Conditions

Chorioamnionitis

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 19, 2016

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share