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TerminatedNCT00675753Updated Dec 17, 2015

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

An observational study in Premature Birth, sponsored by University of Miami. Terminated at 2 sites in United States. Open to participants aged 1 Minute to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-17.

Sponsored by University of Miami · Observational

Why this study was terminated
Study site did not have sufficient subjects for the case group
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
258
Ages
1 Minute to 28 Days
Sex
All
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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).

Read the detailed description

Research Design and Methods

Study Design A gene association study, using a case-control design, will be utilized. Each case and each control will include the genetic mother and her newborn infant.

Setting A multicenter (n=2) study is proposed. St. Mary's Medical Center in West Palm Beach, Florida and Broward General Medical Center in Ft. Lauderdale, Florida are the two research centers.

Sample:

It is estimated that a sample of 166 mother-infant dyads (332 individuals) will be needed to test the study hypotheses. The sample size has been adjusted to allow for a 10% drop out rate. The control group will include 110 term mothers and 110 term infants. The case group will include 56 preterm mothers and 56 preterm infants.

It is expected that each site will be able to enroll 83 family dyads in less than two years. A reasonable effort will be made to enroll eligible family dyads. Enrollment of less than 50% of eligible subjects will lead to a site review to remedy the problem or result in possible site closure. Enrollment for each site will be a minimal of 66 family dyads and a maximum of 100 family dyads.

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Conditions studied

  • Premature Birth

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Keywords

  • Genes
  • Ethnology
  • Cytokines
  • prematurity
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 258 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 28 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study populations were preterm mothers and their infants, born prior to 37 weeks gestation, and term mothers and their infants.

Inclusion criteria

  • Mother and Father, if named on the birth certificate application, are English speaking.
  • If mother and Father are married, husband is the man identified as the father on the birth certificate application.
  • Documentation of Informed Consent for Mother and newborn. Father named on the birth certificate application must consent for newborn to participate.
  • Mother's age (and Father if named on the birth certificate application) is 18 years of age or older.
  • Infant is a singleton, inborn newborn.
  • Newborn gestational age assessment documented in the health record between 23 weeks 0/7 days and 36 weeks 6/7 days.
  • Newborn gestational age assessment documented in the health record > 37 weeks and 0/7 days.
  • Mother identifies herself as Black or African American on the birth certificate application.

Exclusion criteria

Exclusion Criteria:

  • Mother (or Father identified on the birth certificate application) refuses to sign informed consent.
  • Mother (or Father identified on the birth certificate application) does not speak English.
  • Father, identified on the birth certificate application, objects to infant's participation.
  • Husband is not the father named on the birth certificate application.
  • Mother (or Father, if named on the birth certificate application) is less than 18 years of age.
  • Mother fails to identify her ethnic group as Black or African American on the birth certificate application.
  • Mother is cognitively impaired as a result of receiving narcotic analgesia within four hours of the time the research is explained, consent explained, or the interview is conducted.
  • Mother is documented to be cognitively impaired by her physician in the medical record.
  • Father appears to be cognitively impaired at the time the research is explained, consent explained, or the interview is conducted.
  • Mother or infant has a history of blood transfusion in the last six months.
  • Mother had assisted reproduction.
  • Maternal surgical procedures during pregnancy, to include cerclage.
  • Mother has uterine abnormalities.
  • History of trauma prior to the onset of labor.
  • Multiple gestation.
  • Infant has major anomalies (cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, or multiple congenital anomalies).
  • Mother has major anomalies (cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, or multiple congenital anomalies).
  • Infant has documented chromosomal anomalies.
  • Mother has documented chromosomal anomalies.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
258 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Preterm group

    Preterm (36 6/7 weeks gestation or earlier) mothers and their newborns.

    Genetic: Blood spot specimens will be drawn

  • Term group

    Term (\> 37 weeks gestation) mothers and their newborns.

    Genetic: Blood spot specimens will be drawn

Interventions

  • GeneticBlood 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

    Also known as: High risk genetic combinations, Low risk genetic combinations

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What researchers measure

Primary outcomes

  1. 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 and their infants with preterm births and 35% of Black mothers and their infants with term births.

    Time frame: 2 years

Secondary outcomes

  1. To determine the frequency of low risk genetic patterns, as identified by Menon et al. (2006), in Black mothers and their infants with preterm births and Black mothers and their infants with term births.

    Time frame: 2 years

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Study locations

2 sites
  • Broward General Medical Center
    Ft Lauderdale, Florida 33316, United States
  • Broward Medical Center
    Ft. Lauderdale, Florida 33312, United States
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References and documents

Publications

  • Menon R, Velez DR, Simhan H, Ryckman K, Jiang L, Thorsen P, Vogel I, Jacobsson B, Merialdi M, Williams SM, Fortunato SJ. Multilocus interactions at maternal tumor necrosis factor-alpha, tumor necrosis factor receptors, interleukin-6 and interleukin-6 receptor genes predict spontaneous preterm labor in European-American women. Am J Obstet Gynecol. 2006 Jun;194(6):1616-24. doi: 10.1016/j.ajog.2006.03.059. PubMed 16731080 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00675753
Lead sponsor
University of Miami
Collaborators
Pediatrix
Responsible party
Victoria Mitrani (Professor, University of Miami) — Principal investigator
First posted
May 12, 2008
Start date
Sep 2008
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Dec 17, 2015

Study contacts

Gail McCain, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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