The Norwegian Mother and Child Study - Environmental Specimen Collection
Condition: Environmental Determinants; Pregnancy
Study type: Observational

Summary: 
      The Norway Mother and Child study is a collaborative venture among health researchers in
      Norway funded by the Norwegian government. The study is being coordinated by the National
      Institute of Public Health (aka Folkehelsa) in Oslo and the Medical Birth Registry (MBR) in
      Bergen. NIEHS has the unique opportunity to participate through the collection of additional
      tubes of blood during the blood sample collection; these two tubes of blood and a urine
      sample will allow NIEHS and collaborators to explore environmental determinants for disease
      among women and their children. These additional samples will remain in the Biobank in Oslo,
      Norway, with other samples from cohort members and will be used under collaboration with
      Norwegian investigators.

      To achieve better health for mothers and children in the future, the Norway Mother and Child
      study is designed to test specific hypotheses about the causes of a number of serious
      diseases by recruiting 110,000 pregnant women to a cohort study. As part of the primary aim
      of the study, women will be asked to provide a blood sample at 17 weeks gestation, at birth,
      and 4 days after birth. The NIEHS samples will be collected at the blood draw at 17 weeks
      gestation. Likely causal factors will be linked to information obtained from questionnaires,
      blood samples, and medical registers.

      The Norway Mother and Child study has multiple endpoints. Primarily those associated with
      adverse pregnancy outcomes will be studied, but also diseases affecting mother, father or
      child. Endpoints will be taken from questionnaires and medical registers. The study will be
      carried out nationally and any research groups with relevant questions will be able to
      participate. The Norway Mother and Child study has been approved by the Norwegian Parliament
      as well as their Data Inspectorate to ensure that the study and all protocols conform to
      Norwegian ethical standards as well as appropriate research ethical criteria. Further, the
      project has been evaluated by the Regional Ethics Committee for Medical Research which has
      approved all modifications to the project.

      Other researchers, nationally and internationally, will have access to the cohort on request
      and following approval from the project's executive group. NIEHS has the opportunity to add
      additional biological specimens for blood and urine to the base cohort. Two additional tubes
      of blood (total volume 9 ml) and a urine sample will be collected as part of the routine
      prenatal ultrasound visit and blood sample collection included in the overall study protocol.
      As part of a reliability sub-study, blood and urine samples will also be collected an
      additional two times, at weeks 23 and 29 of gestation. These samples are designed to allow
      investigators to explore environmental contributors to the health of women and their
      children. Low level exposure to environmental contaminants occurs in all industrialized
      countries, though the level of exposure may differ as the result of diet, cooking practices
      and pollution sources. However, the ability to explore the role of environmental exposure on
      health is often more limited by good population-based information on health and disease then
      by exposure level. Thus, by creating a biological specimen repository in a country with
      excellent disease registries, it will allow NIEHS to explore risk factors for disease
      relevant to US populations. All samples will be stored in Norway and will be used in
      collaboration with Norwegian and other investigators. NIEHS investigators will not have
      access to identifying information. NIEHS samples will not be used for genetic analyses.

      ...
    

Detailed description: 
      The Norway Mother and Child study is a collaborative venture among health researchers in
      Norway funded by the Norwegian government. The study is being coordinated by the National
      Institute of Public Health (aka Folkehelsa) in Oslo and the Medical Birth Registry (MBR) in
      Bergen. NIEHS has the unique opportunity to participate through the collection of additional
      tubes of blood during the blood sample collection; these two tubes of blood and a urine
      sample will allow NIEHS and collaborators to explore environmental determinants for disease
      among women and their children. These additional samples will remain in the Biobank in Oslo,
      Norway, with other samples from cohort members and will be used under collaboration with
      Norwegian investigators.

      To achieve better health for mothers and children in the future, the Norway Mother and Child
      study is designed to test specific hypotheses about the causes of a number of serious
      diseases by recruiting 110,000 pregnant women to a cohort study. As part of the primary aim
      of the study, women will be asked to provide a blood sample at 17 weeks gestation, at birth,
      and 4 days after birth. The NIEHS samples will be collected at the blood draw at 17 weeks
      gestation. Likely causal factors will be linked to information obtained from questionnaires,
      blood samples, and medical registers.

      The Norway Mother and Child study has multiple endpoints. Primarily those associated with
      adverse pregnancy outcomes will be studied, but also diseases affecting mother, father or
      child. Endpoints will be taken from questionnaires and medical registers. The study will be
      carried out nationally and any research groups with relevant questions will be able to
      participate. The Norway Mother and Child study has been approved by the Norwegian Parliament
      as well as their Data Inspectorate to ensure that the study and all protocols conform to
      Norwegian ethical standards as well as appropriate research ethical criteria. Further, the
      project has been evaluated by the Regional Ethics Committee for Medical Research which has
      approved all modifications to the project.

      Other researchers, nationally and internationally, will have access to the cohort on request
      and following approval from the project's executive group. NIEHS has the opportunity to add
      additional biological specimens for blood and urine to the base cohort. Two additional tubes
      of blood (total volume 9 ml) and a urine sample will be collected as part of the routine
      prenatal ultrasound visit and blood sample collection included in the overall study protocol.
      As part of a reliability sub-study, blood and urine samples will also be collected an
      additional two times, at weeks 23 and 29 of gestation. These samples are designed to allow
      investigators to explore environmental contributors to the health of women and their
      children. Low level exposure to environmental contaminants occurs in all industrialized
      countries, though the level of exposure may differ as the result of diet, cooking practices
      and pollution sources. However, the ability to explore the role of environmental exposure on
      health is often more limited by good population-based information on health and disease then
      by exposure level. Thus, by creating a biological specimen repository in a country with
      excellent disease registries, it will allow NIEHS to explore risk factors for disease
      relevant to US populations. All samples will be stored in Norway and will be used in
      collaboration with Norwegian and other investigators. NIEHS investigators will not have
      access to identifying information. NIEHS samples will not be used for genetic analyses.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Norwegian pregnant women are prospectively followed beginning with the 17th week of
        pregnancy. Their children born after enrollment are prospectively followed into adulthood.
        Enrolled children's fathers are prospectively followed as well.@@@@@@
      
Keywords: Disease Activity; Pregnancy; Exposure; Norway Mother and Child Study