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Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families

NCT00675753 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 258

Last updated 2015-12-17

No results posted yet for this study

Summary

A multilocus interaction of three pro-inflammatory cytokine single nucleotide polymorphisms (SNPs), -3448 Tumor Necrosis Factor-α, -7227 Interleukin 6, and 33314 Interleukin 6R was reported by Menon and associates in 2006. The researchers reported that they were able to predict spontaneous preterm birth in 65.2% of a population restricted to European-American mothers. Expansion of this research is needed to determine if the results are also applicable in Black populations.

Statement of Purpose The purpose of this research is to determine if the multi-locus genetic interaction of tumor necrosis factor-α (-3448), interleukin 6 (-7227), and interleukin 6R (33314), as described by Menon et al. (2006), is associated with preterm birth in Black mother-infant dyads.

Research Aims and Hypotheses:

Primary Aim 1.0: To determine if carriage of one of the high risk genetic patterns, as identified by Menon et al. (2006), is present in 65% of Black mothers with preterm births and 35% of Black mothers with term births.

Hypothesis 1.0: There is no statistically significant difference in the occurrence of one of the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population of Black mothers with preterm births (case) and Black mothers with term births (controls).

Primary Aim 2.0: To determine if carriage of one of the high risk genetic patterns, as identified by Menon et al. (2006), is present in 65% of Black preterm newborns and 35% of Black term newborns.

Hypothesis 2.0: There is no statistically significant difference in the occurrence of one of the eight high risk genetic patterns, as identified by Menon et al. (2006), in a population of Black preterm newborns (case) and Black term newborns (controls).

Conditions

  • Premature Birth

Interventions

GENETIC

Blood spot specimens will be drawn

Blood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping

Sponsors & Collaborators

  • Pediatrix

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Gail McCain, PhD · University of Miami

Eligibility

Min Age
1 Minute
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675753 on ClinicalTrials.gov