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Genetic Variations in Three Interacting Single Nucleotide Polymorphisms and the Risk of Preterm Birth in Black Families


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Premature Birth

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Trial Information

Genetic Variations in Three Interacting Single Nucleotide Polymorphisms and the Risk of Preterm Birth in Black Families


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.


Inclusion Criteria:



1. Mother and Father, if named on the birth certificate application, are English
speaking.

2. If mother and Father are married, husband is the man identified as the father on the
birth certificate application.

3. Documentation of Informed Consent for Mother and newborn. Father named on the birth
certificate application must consent for newborn to participate.

4. Mother's age (and Father if named on the birth certificate application) is 18 years
of age or older.

5. Infant is a singleton, inborn newborn.

6. Newborn gestational age assessment documented in the health record between 23 weeks
0/7 days and 36 weeks 6/7 days.

7. Newborn gestational age assessment documented in the health record > 37 weeks and 0/7
days.

8. Mother identifies herself as Black or African American on the birth certificate
application.

Exclusion Criteria

1. Mother (or Father identified on the birth certificate application) refuses to sign
informed consent.

2. Mother (or Father identified on the birth certificate application) does not speak
English.

3. Father, identified on the birth certificate application, objects to infant's
participation.

4. Husband is not the father named on the birth certificate application.

5. Mother (or Father, if named on the birth certificate application) is less than 18
years of age.

6. Mother fails to identify her ethnic group as Black or African American on the birth
certificate application.

7. 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.

8. Mother is documented to be cognitively impaired by her physician in the medical
record.

9. Father appears to be cognitively impaired at the time the research is explained,
consent explained, or the interview is conducted.

10. Mother or infant has a history of blood transfusion in the last six months.

11. Mother had assisted reproduction.

12. Maternal surgical procedures during pregnancy, to include cerclage.

13. Mother has uterine abnormalities.

14. History of trauma prior to the onset of labor.

15. Multiple gestation.

16. 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).

17. 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).

18. Infant has documented chromosomal anomalies.

19. Mother has documented chromosomal anomalies.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gail McCain, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami

Authority:

United States: Institutional Review Board

Study ID:

20070609

NCT ID:

NCT00675753

Start Date:

June 2008

Completion Date:

October 2010

Related Keywords:

  • Premature Birth
  • Genes
  • Ethnology
  • Cytokines
  • prematurity
  • Premature Birth

Name

Location

Broward General Medical CenterFort Lauderdale, Florida  33316