Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00340860 |
Other study ID # |
999902206 |
Secondary ID |
02-E-N206 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2001 |
Est. completion date |
October 16, 2020 |
Study information
Verified date |
October 2020 |
Source |
National Institutes of Health Clinical Center (CC) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
...
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.