Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Miami.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pediatrix Medical Group
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT00675753
First received: May 7, 2008
Last updated: May 9, 2008
Last verified: May 2008

May 7, 2008
May 9, 2008
June 2008
June 2010   (final data collection date for primary 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675753 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
Genetic Variations in Three Interacting Single Nucleotide Polymorphisms and the Risk of Preterm Birth in Black Families

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Premature Birth
Other: Blood spot specimens will be drawn
Blood spot specimens will be drawn from mother-baby dyads in the control and experiemental groups and sent for genotyping
  • Experimental: A
    Preterm (36 6/7 weeks gestation or earlier) mothers and their newborns.
    Intervention: Other: Blood spot specimens will be drawn
  • Active Comparator: B
    Term (> 37 weeks gestation) mothers and their newborns.
    Intervention: Other: Blood spot specimens will be drawn
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
110
October 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
up to 28 Days
Yes
Contact: Margaret Steinbach, MSN 800-243-3839 ext 5027 margaret_steinbach@pediatrix.com
Contact: Gail McCain, PhD 305-284-2904 gmccain@miami.edu
United States
 
NCT00675753
20070609
Yes
Margaret Steinbach, PhD Candidate (Gail McCain, PhD is the UM PI for the study), University of Miami School of Nursing
University of Miami
Pediatrix Medical Group
Principal Investigator: Gail McCain, PhD University of Miami
University of Miami
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP