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

This study has been terminated.
(Study site did not have sufficient subjects for the case group)
Sponsor:
Collaborator:
Mednax Center for Research, Education and Quality
Information provided by (Responsible Party):
Victoria Mitrani, University of Miami
ClinicalTrials.gov Identifier:
NCT00675753
First received: May 7, 2008
Last updated: December 16, 2015
Last verified: December 2015
  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
Genetic: Blood spot specimens will be drawn

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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 ]

Biospecimen Retention:   Samples With DNA
Blood spot specimens were collected from the mother and her infant.

Enrollment: 258
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preterm group
Preterm (36 6/7 weeks gestation or earlier) mothers and their newborns.
Genetic: Blood spot specimens will be drawn
Blood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping
Other Names:
  • High risk genetic combinations
  • Low risk genetic combinations
Term group
Term (> 37 weeks gestation) mothers and their newborns.
Genetic: Blood spot specimens will be drawn
Blood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping
Other Names:
  • High risk genetic combinations
  • Low risk genetic combinations

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   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study populations were preterm mothers and their infants, born prior to 37 weeks gestation, and term mothers and their infants.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Broward General Medical Center
Ft Lauderdale, Florida, United States, 33316
Broward Medical Center
Ft. Lauderdale, Florida, United States, 33312
Sponsors and Collaborators
University of Miami
Mednax Center for Research, Education and Quality
Investigators
Principal Investigator: Gail McCain, PhD University of Miami
  More Information

Publications:
Responsible Party: Victoria Mitrani, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00675753     History of Changes
Other Study ID Numbers: 20070609 
Study First Received: May 7, 2008
Last Updated: December 16, 2015
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 August 25, 2016