Birth WeightNCT05810545
Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity
An observational study of Birth Weight and Small for Gestational Age at Delivery, run by Karolinska Institutet.
Trial summary
The aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Birth Weight, Small for Gestational Age at Delivery, Large for Gestational Age at Delivery (Macrosomia)
- What is being tested?
- Per- and polyfluoroalkyl substances (PFAS)
- How many people
- 256,659 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2018
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018, where PFAS exposure data is available.
Who may be able to join
- Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018
Who cannot join
- Lack of data of PFAS levels in municipal drinking water (entire localities excluded)
- Mothers not living in the study area consistently between first trimester and four years prior to birth
About this study
The aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.
- Conditions
- Birth Weight, Small for Gestational Age at Delivery, Large for Gestational Age at Delivery (Macrosomia), Diabetes, Gestational, Hypertension in Pregnancy, Preeclampsia
- Being tested
- Per- and polyfluoroalkyl substances (PFAS)
- Medical subject headings
- Birth Weight, Diabetes, Gestational, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per- and polyfluoroalkyl substances (PFAS)Other
Assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register based cohort.
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth outcome - birthweight
grams as measured at birth
Measured: at birth
Birth outcome - Small for gestational age (SGA)
<-2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)
Measured: at birth
Birth outcome - Large for gestational age (LGA)
>2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)
Measured: at birth
Birth outcome - major congenital malformations
ICD10- codes: Q00-Q99 within the first 28 days postpartum, categorized as major congenital malformations according to European Surveillance of Congenital Anomalies (EUROCAT 2014)
Measured: at birth
Maternal health - Gestational hypertension/preeclampsia
ICD10-codes: O13-O14. Diagnosis at maternal or primary care
Measured: during gestation
Maternal health - Gestational diabetes mellus
ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care
Measured: during gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 256,659 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), The Swedish Research Council, Statistics Sweden, National Board of Health and Welfare, Sweden, Swedish University of Agricultural Sciences, Swedish Food Agency
- Responsible party
- Principal investigator, Agneta Åkesson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810545
- Sponsor's protocol ID
- EXP-21-CV8301
- Other IDs
- 2022-00980
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is available from registers at Statistics Sweden and National Board of Health and Welfare in Sweden.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drinking Water PFAS, Pregnancy Outcome and Maternal Morbidity
- ClinicalTrials.gov ID
- NCT05810545
- Acronym / sponsor ID
- EXP-21-CV8301
- Conditions
- Birth Weight, Small for Gestational Age at Delivery, Large for Gestational Age at Delivery (Macrosomia), Diabetes, Gestational, Hypertension in Pregnancy, Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256,659 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS), The Swedish Research Council, Statistics Sweden, National Board of Health and Welfare, Sweden, Swedish University of Agricultural Sciences, Swedish Food Agency
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Apr 2023 (actual)
- 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 aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018, where PFAS exposure data is available.
Key inclusion criteria (1 listed)
- Pregnant women residing in Swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018
Key exclusion criteria (2 listed)
- Lack of data of PFAS levels in municipal drinking water (entire localities excluded)
- Mothers not living in the study area consistently between first trimester and four years prior to birth
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 |
|---|---|---|
| Per- and polyfluoroalkyl substances (PFAS)Assess the association between exposure to per- and polyfluoroalkyl substances (PFAS) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register based cohort. | Other | – |
Primary outcome
Birth outcome - birthweight
Time frame: at birth
grams as measured at birth
Birth outcome - Small for gestational age (SGA)
Time frame: at birth
<-2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)
Birth outcome - Large for gestational age (LGA)
Time frame: at birth
>2 standard deviations (SD) from the average weight at the gestational age and sex at partus (Marsal et al. 1996. Acta Paediatr 85(7): 843-848)
Birth outcome - major congenital malformations
Time frame: at birth
ICD10- codes: Q00-Q99 within the first 28 days postpartum, categorized as major congenital malformations according to European Surveillance of Congenital Anomalies (EUROCAT 2014)
Maternal health - Gestational hypertension/preeclampsia
Time frame: during gestation
ICD10-codes: O13-O14. Diagnosis at maternal or primary care
Maternal health - Gestational diabetes mellus
Time frame: during gestation
ICD10-codes: O24 (excluding pregestational diabetes). Diagnosis at maternal or primary care
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 18 Apr 2023.
- Individual participant dataSharing planned: No. IPD is available from registers at Statistics Sweden and National Board of Health and Welfare in Sweden.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Weight and Small for Gestational Age at Delivery, run by Karolinska Institutet.
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 2 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Birth outcome - birthweight (time frame: at birth). The study lists 6 primary outcomes in all. 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 18 Apr 2023.