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

NCT00675753 | Terminated DMC

• 1 other identifier: 20070609
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Genes; Ethnology; Cytokines; prematurity

Outcome Measures

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.

  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.

  2 years

Study Arms (2)

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

Blood spot specimens will be drawn GENETIC

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

Preterm group; Term group

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Pediatrix: collaborator

Study Sites (2)

Broward Medical Center

Fort Lauderdale, Florida, 33312, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Related Publications (1)

• 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.

  PMID: 16731080 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood spot specimens were collected from the mother and her infant.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Gail McCain, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 12, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

US (2)