Trial record 15 of 372 for:    "african american" | Open Studies

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
  Purpose

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).


Condition Intervention
Premature Birth
Other: Blood spot specimens will be drawn

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Genetic Variations in Three Interacting Single Nucleotide Polymorphisms and the Risk of Preterm Birth in Black Families

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: June 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Preterm (36 6/7 weeks gestation or earlier) mothers and their newborns.
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
Active Comparator: B
Term (> 37 weeks gestation) mothers and their newborns.
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

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.

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675753

Contacts
Contact: Margaret Steinbach, MSN 800-243-3839 ext 5027 margaret_steinbach@pediatrix.com
Contact: Gail McCain, PhD 305-284-2904 gmccain@miami.edu

Locations
United States, Florida
Broward General Medical Center Not yet recruiting
Ft Lauderdale, Florida, United States, 33316
Contact: Margaret Steinbach, MSN    800-243-3839 ext 5027    margaret_steinbach@pediatrix.com   
Contact: Gail McCain, PhD    305-284-2904    gmccain@miami.edu   
Principal Investigator: Margaret Steinbach, MSN         
Sponsors and Collaborators
University of Miami
Pediatrix Medical Group
Investigators
Principal Investigator: Gail McCain, PhD University of Miami
  More Information

Publications:
Responsible Party: Margaret Steinbach, PhD Candidate (Gail McCain, PhD is the UM PI for the study), University of Miami School of Nursing
ClinicalTrials.gov Identifier: NCT00675753     History of Changes
Other Study ID Numbers: 20070609
Study First Received: May 7, 2008
Last Updated: May 9, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Genes
Ethnology
Cytokines
prematurity

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014