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

Stopped early

Conditions studied: Premature Birth

In brief

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).

Key facts

Study ID

NCT00675753

Run by

University of Miami

People needed

258

Starts

2008-09-01

Expected to finish

2009-08-01

Last updated by the study team

2015-12-17

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

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.
• 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.

Where it is running

• Broward Medical Center — Fort Lauderdale, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

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