Status:
TERMINATED
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Pediatrix
Conditions:
Premature Birth
Eligibility:
All Genders
1-28 years
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 a...
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. S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT00675753
Start Date
September 1 2008
End Date
August 1 2009
Last Update
December 17 2015
Active Locations (2)
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1
Broward Medical Center
Fort Lauderdale, Florida, United States, 33312
2
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316