NCT00970151

Brief Summary

The hypothesis of this study is that maternal and fetal biologic variation in the balance between pro-inflammatory and anti-inflammatory mediators can be measured by currently available techniques. In addition, the investigators hypothesize that a pro-inflammatory maternal phenotype increases the risk of fetal exposure to intrauterine hyperthemia and inflammatory cytokines; and that intrapartum events, especially known risk factors for fever at term such as epidural analgesia and prolonged rupture of membranes, may interact with underlying maternal factors to increase fetal exposure to inflammatory cytokines. This experiment aims to establish the first large-scale cohort to evaluate biomarkers for maternal and fetal inflammation in term pregnancy and to elucidate the relative antepartum and intrapartum contributions to fetal inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
618

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
Last Updated

October 12, 2009

Status Verified

October 1, 2009

Enrollment Period

4.2 years

First QC Date

February 19, 2008

Last Update Submit

October 9, 2009

Conditions

Maternal-Fetal Relations

Keywords

Fetal InflammationBirth OutcomePregnancy

Outcome Measures

Primary Outcomes (1)

  • Fetal exposure to inflammation as assessed by cord cytokine levels

    During birth

Eligibility Criteria

Age14 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

600 racially and ethnically diverse nulliparas who present to the Prenatal Wellness Center at Cannon Place and Northwoods Clinic with a full term (\>37 weeks) pregnancy and who deliver in the Labor and Delivery Suite at MUSC Hospital

You may qualify if:

  • Nulliparity
  • Singleton gestation
  • Full term (\>37 weeks) pregnancy
  • Vertex presentation
  • Candidate for trial of labor
  • Ability to provide informed consent

You may not qualify if:

  • Multiple gestation
  • Autoimmune Disease
  • Treatment with anti-inflammatory agents during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Univeristy of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, blood serum, placenta, spinal fluid (for some subjects)

Study Officials

  • Laura Goetzl, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

September 2, 2009

Study Start

June 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 12, 2009

Record last verified: 2009-10

Locations

US(1)