Premature BirthNCT00675753
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
An observational study of Premature Birth, run by University of Miami at 2 sites in United States.
Trial 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 and associates in 2006. Read more about this study
- Who is it for?
- Ages 1 minute to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Blood spot specimens will be drawn
- How many people
- 258 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study populations were preterm mothers and their infants, born prior to 37 weeks gestation, and term mothers and their infants.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Broward Medical Center
Fort Lauderdale, Florida, 33312
Broward General Medical Center
Fort Lauderdale, Florida, 33316
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Blood spot specimens will be drawn
- Keywords
- Genes, Ethnology, Cytokines, prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood spot specimens will be drawnGenetic
Also called High risk genetic combinations, Low risk genetic combinations
Blood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping
| Study group | Role | What they receive |
|---|---|---|
| Preterm group | Preterm (36 6/7 weeks gestation or earlier) mothers and their newborns. Receives: Genetic: Blood spot specimens will be drawn | |
| Term group | Term (> 37 weeks gestation) mothers and their newborns. Receives: Genetic: Blood spot specimens will be drawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Study site did not have sufficient subjects for the case group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatrix
- Responsible party
- Principal investigator, Victoria Mitrani, University of Miami
- Investigators
- Gail McCain, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675753
- Sponsor's protocol ID
- 20070609
- Status last verified
- Dec 2015
- First submitted
- 7 May 2008
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1016/j.ajog.2006.03.059.
PubMed 16731080
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variations in Three Interacting Single Nucleotide Polymorphisms and the Risk of Preterm Birth in Black Families
- ClinicalTrials.gov ID
- NCT00675753
- Acronym / sponsor ID
- 20070609
- Conditions
- Premature Birth
- Keywords
- Genes, Ethnology, Cytokines, prematurity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study site did not have sufficient subjects for the case group
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Pediatrix
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm group | – | Genetic: Blood spot specimens will be drawnPreterm (36 6/7 weeks gestation or earlier) mothers and their newborns. |
| Term group | – | Genetic: Blood spot specimens will be drawnTerm (> 37 weeks gestation) mothers and their newborns. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study populations were preterm mothers and their infants, born prior to 37 weeks gestation, and term mothers and their infants.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood spot specimens will be drawnAlso: High risk genetic combinations, Low risk genetic combinationsBlood spot specimens will be drawn from mother-baby dyads in the control and experimental groups and sent for genotyping | Genetic | Preterm group, Term group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Study site did not have sufficient subjects for the case group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Background: PubMed 16731080Menon 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. doi: 10.1016/j.ajog.2006.03.059.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail McCain, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study site did not have sufficient subjects for the case group). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00675753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.