Environmental DeterminantsNCT00340860
The Norwegian Mother and Child Study - Environmental Specimen Collection
An observational study of Environmental Determinants and Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Environmental Determinants, Pregnancy
- How many people
- 81,093 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2001to 16 Oct 2020
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.@@@@@@
Who may be able to join
- The study sample will be all pregnant women scheduled for routine ultrasound at 16-18 weeks gestation.
Who cannot join
- Women who do not speak Norwegian are excluded because they cannot complete the questionnaires.
- RELIABILITY SUB-STUDY ELIGIBILITY CRITERIA:
- Subjects must be enrolled in the Norway Mother and Child Study at one of four participating hospitals and have successfully completed a blood draw and urine collection in the 17th week of gestation.
- SEVEN-YEAR FOLLOW-UP PILOT STUDY ELIGIBILITY CRITERIA:
- Mothers and children must be enrolled in the Norway Mother and Child Study and the child must turn seven years of age during pilot enrollment in 2008 and 2009.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
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Read the 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.
- Conditions
- Environmental Determinants, Pregnancy
- Keywords
- Disease Activity, Pregnancy, Exposure, Norway Mother and Child Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Norweigian Population-Based Pregnancy Cohort | Norwegian-speaking pregnant women, their children born post enrollment, and enrolled children's fathers |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIEHS samples will be used to assess the role of environmental exposures on health
Adverse pregnancy outcomes
Measured: 17, 23, and 29 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Oct 2001
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental DeterminantsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gitanjali Taneja, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340860
- Sponsor's protocol ID
- 999902206
- Other IDs
- 02-E-N206
- Status last verified
- Oct 2020
- First submitted
- 19 Jun 2006
- Last updated
- 22 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian Mother and Child Study - Environmental Specimen Collection
- ClinicalTrials.gov ID
- NCT00340860
- Acronym / sponsor ID
- 999902206
- Conditions
- Environmental Determinants, Pregnancy
- Keywords
- Disease Activity, Pregnancy, Exposure, Norway Mother and Child Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,093 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Oct 2001 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 21 Jun 2006 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norweigian Population-Based Pregnancy Cohort | – | –Norwegian-speaking pregnant women, their children born post enrollment, and enrolled children's fathers |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.@@@@@@
Key inclusion criteria (1 listed)
- The study sample will be all pregnant women scheduled for routine ultrasound at 16-18 weeks gestation.
Key exclusion criteria (5 listed)
- Women who do not speak Norwegian are excluded because they cannot complete the questionnaires.
- Subjects must be enrolled in the Norway Mother and Child Study at one of four participating hospitals and have successfully completed a blood draw and urine collection in the 17th week of gestation.
- Mothers and children must be enrolled in the Norway Mother and Child Study and the child must turn seven years of age during pilot enrollment in 2008 and 2009.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NIEHS samples will be used to assess the role of environmental exposures on health
Time frame: 17, 23, and 29 weeks gestation
Adverse pregnancy outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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.
Gitanjali Taneja, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environmental Determinants and Pregnancy, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in Norway.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NIEHS samples will be used to assess the role of environmental exposures on health (time frame: 17, 23, and 29 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2020.