Healthy VolunteerSEPAGES-1337NCT02852499
Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
An observational study of Healthy Volunteer, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on the general population and aims to cover several areas of environmental health research, including endocrine disruptors and air… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Urine sampling, Carry a GPS and BET and Carry pollution sensor
- How many people
- 1,010 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jan 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women before 19 getsationel week, older than 18 years old Father of the children Children at birth
Who may be able to join
- pregnant women
- < 19 gestational weeks
- > 18 years old
- living in the area of Grenoble
- planning to give birth in one of the four maternities located in Grenoble
Who cannot join
- not speaking French
- no access to the French social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on the general population and aims to cover several areas of environmental health research, including endocrine disruptors and air pollutants.
The main objectives is to quantify the impact of pollution during pregnancy and the first years of life on three main health outcomes : growth, respiratory health and neuro-development ; and to better understand the biological mechanism (such as genetic analysis to study the role of environmental factors on genes expression as well as the role of genetic factors on health). The objective is to include 500 families.
Read the detailed description
SEPAGES is a new type of longitudinal couple-child cohort with repeated clinical examinations during pregnancy and childhood, extensive collection of repeated biological samples from both parents and the child, use of new technologies to assess exposure to air pollution (GPS, personal dosimeter etc.) Throughout the study (during pregnancy and the first years of the child's life), clinical examination and many biological tests (urine, blood, hair) are performed. Exposure to different environmental factors are made several times during pregnancy and the first years of the child's life thanks to personal dosimeters, GPS and accelerometers. During labor and childbirth a number of samples are taken (placenta, tissues, blood, urines, hair, meconium and breast milk). Finally, during the study a number of evaluation questionnaires are given to volunteers via a computer platform in order to have a better understanding of the environment in which they are living.
The SEPAGES cohort follows the rule of the biomedical research. Informed consents are signed by both the father and the mother during the inclusion visit which takes place in the hospital. All ethical and data privacy agreements had been obtained : a favorable opinion was issued by the Comité de Protection des Personnes (CPP) on November 13th, 201 and by the CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé) on January 09th, 2014. The study was authorised by the Agence Nationale de Sécurité du Médicament(ANSM), on Decmber 17th, 2013 and by the Comité Nationale de l'Informatique et des Libertés (CNIL) on June 26th, 2014.
- Conditions
- Healthy Volunteer
- Being tested
- Urine sampling, Carry a GPS and BET, Carry pollution sensor, Sampling at the maternity, Self-questionnaires
- Keywords
- environmental epidemiology, cohort, atmospheric pollutant, chemical pollutant, growth, neuro-development, respiratory health, big data, biological samples (RNA, DNA, urines ...), e-dohad and exposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine samplingOther
Carry a GPS and BETOther
Carry pollution sensorOther
Sampling at the maternityOther
Self-questionnairesOther
Sampling in partum periodOther
Meconium and a strand of hair.
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Pregnant women. Receives: Other: Urine sampling; Other: Carry a GPS and BET; Other: Carry pollution sensor; Other: Sampling at the maternity; Other: Self-questionnaires | |
| Fathers | Futur fathers. Receives: Other: Urine sampling; Other: Self-questionnaires | |
| Children | Children after childbirth. Receives: Other: Sampling in partum period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical exam : biological sampling
Sampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g
Measured: Up to one hour
Clinical exam : biological sampling
Sampling of : urines, blood in mL
Measured: Up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionFeb 2018
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- iSABELLE Pin, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852499
- Sponsor's protocol ID
- 38RC13.579
- Acronym
- SEPAGES-1337
- Status last verified
- Dec 2019
- First submitted
- 26 May 2016
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Barker DJ, Osmond C, Golding J, Kuh D, Wadsworth ME. Growth in utero, blood pressure in childhood and adult life, and mortality from cardiovascular disease. BMJ. 1989 Mar 4;298(6673):564-7. doi: 10.1136/bmj.298.6673.564.
PubMed 2495113Barker DJ, Winter PD, Osmond C, Margetts B, Simmonds SJ. Weight in infancy and death from ischaemic heart disease. Lancet. 1989 Sep 9;2(8663):577-80. doi: 10.1016/s0140-6736(89)90710-1.
PubMed 2570282Barker DJ. The developmental origins of adult disease. J Am Coll Nutr. 2004 Dec;23(6 Suppl):588S-595S. doi: 10.1080/07315724.2004.10719428.
PubMed 15640511Lawlor DA, Ebrahim S, Davey Smith G. Association of birth weight with adult lung function: findings from the British Women's Heart and Health Study and a meta-analysis. Thorax. 2005 Oct;60(10):851-8. doi: 10.1136/thx.2005.042408. Epub 2005 Jul 29.
PubMed 16055617Rona RJ, Gulliford MC, Chinn S. Effects of prematurity and intrauterine growth on respiratory health and lung function in childhood. BMJ. 1993 Mar 27;306(6881):817-20. doi: 10.1136/bmj.306.6881.817.
PubMed 8490372Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.
PubMed 7800004Haland G, Carlsen KC, Sandvik L, Devulapalli CS, Munthe-Kaas MC, Pettersen M, Carlsen KH; ORAACLE. Reduced lung function at birth and the risk of asthma at 10 years of age. N Engl J Med. 2006 Oct 19;355(16):1682-9. doi: 10.1056/NEJMoa052885.
PubMed 17050892Stern DA, Morgan WJ, Wright AL, Guerra S, Martinez FD. Poor airway function in early infancy and lung function by age 22 years: a non-selective longitudinal cohort study. Lancet. 2007 Sep 1;370(9589):758-64. doi: 10.1016/S0140-6736(07)61379-8.
PubMed 17765525Jensen TK, Jorgensen N, Punab M, Haugen TB, Suominen J, Zilaitiene B, Horte A, Andersen AG, Carlsen E, Magnus O, Matulevicius V, Nermoen I, Vierula M, Keiding N, Toppari J, Skakkebaek NE. Association of in utero exposure to maternal smoking with reduced semen quality and testis size in adulthood: a cross-sectional study of 1,770 young men from the general population in five European countries. Am J Epidemiol. 2004 Jan 1;159(1):49-58. doi: 10.1093/aje/kwh002.
PubMed 14693659Moshammer H, Hoek G, Luttmann-Gibson H, Neuberger MA, Antova T, Gehring U, Hruba F, Pattenden S, Rudnai P, Slachtova H, Zlotkowska R, Fletcher T. Parental smoking and lung function in children: an international study. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1255-63. doi: 10.1164/rccm.200510-1552OC. Epub 2006 Feb 16.
PubMed 16484675McKeever TM, Lewis SA, Smith C, Collins J, Heatlie H, Frischer M, Hubbard R. Early exposure to infections and antibiotics and the incidence of allergic disease: a birth cohort study with the West Midlands General Practice Research Database. J Allergy Clin Immunol. 2002 Jan;109(1):43-50. doi: 10.1067/mai.2002.121016.
PubMed 11799364Li YF, Langholz B, Salam MT, Gilliland FD. Maternal and grandmaternal smoking patterns are associated with early childhood asthma. Chest. 2005 Apr;127(4):1232-41. doi: 10.1378/chest.127.4.1232.
PubMed 15821200Shaheen SO, Sterne JA, Montgomery SM, Azima H. Birth weight, body mass index and asthma in young adults. Thorax. 1999 May;54(5):396-402. doi: 10.1136/thx.54.5.396.
PubMed 10212102Miller RL, Ho SM. Environmental epigenetics and asthma: current concepts and call for studies. Am J Respir Crit Care Med. 2008 Mar 15;177(6):567-73. doi: 10.1164/rccm.200710-1511PP. Epub 2008 Jan 10.
PubMed 18187692Breton CV, Byun HM, Wenten M, Pan F, Yang A, Gilliland FD. Prenatal tobacco smoke exposure affects global and gene-specific DNA methylation. Am J Respir Crit Care Med. 2009 Sep 1;180(5):462-7. doi: 10.1164/rccm.200901-0135OC. Epub 2009 Jun 4.
PubMed 19498054
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEPAGES : Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health
- ClinicalTrials.gov ID
- NCT02852499
- Acronym / sponsor ID
- SEPAGES-1337 / 38RC13.579
- Conditions
- Healthy Volunteer
- Keywords
- environmental epidemiology, cohort, atmospheric pollutant, chemical pollutant, growth, neuro-development, respiratory health, big data, biological samples (RNA, DNA, urines ...), e-dohad and exposome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jul 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jan 2021 (estimated)
- First posted
- 2 Aug 2016 (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 SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on the general population and aims to cover several areas of environmental health research, including endocrine disruptors and air pollutants.
The main objectives is to quantify the impact of pollution during pregnancy and the first years of life on three main health outcomes : growth, respiratory health and neuro-development ; and to better understand the biological mechanism (such as genetic analysis to study the role of environmental factors on genes expression as well as the role of genetic factors on health). The objective is to include 500 families.
Detailed description
SEPAGES is a new type of longitudinal couple-child cohort with repeated clinical examinations during pregnancy and childhood, extensive collection of repeated biological samples from both parents and the child, use of new technologies to assess exposure to air pollution (GPS, personal dosimeter etc.) Throughout the study (during pregnancy and the first years of the child's life), clinical examination and many biological tests (urine, blood, hair) are performed. Exposure to different environmental factors are made several times during pregnancy and the first years of the child's life thanks to personal dosimeters, GPS and accelerometers. During labor and childbirth a number of samples are taken (placenta, tissues, blood, urines, hair, meconium and breast milk). Finally, during the study a number of evaluation questionnaires are given to volunteers via a computer platform in order to have a better understanding of the environment in which they are living.
The SEPAGES cohort follows the rule of the biomedical research. Informed consents are signed by both the father and the mother during the inclusion visit which takes place in the hospital. All ethical and data privacy agreements had been obtained : a favorable opinion was issued by the Comité de Protection des Personnes (CPP) on November 13th, 201 and by the CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé) on January 09th, 2014. The study was authorised by the Agence Nationale de Sécurité du Médicament(ANSM), on Decmber 17th, 2013 and by the Comité Nationale de l'Informatique et des Libertés (CNIL) on June 26th, 2014.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: Urine sampling, Other: Carry a GPS and BET, Other: Carry pollution sensor, Other: Sampling at the maternity, Other: Self-questionnairesPregnant women. |
| Fathers | – | Other: Urine sampling, Other: Self-questionnairesFutur fathers. |
| Children | – | Other: Sampling in partum periodChildren after childbirth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women before 19 getsationel week, older than 18 years old Father of the children Children at birth
Key inclusion criteria (5 listed)
- pregnant women
- < 19 gestational weeks
- > 18 years old
- living in the area of Grenoble
- planning to give birth in one of the four maternities located in Grenoble
Key exclusion criteria (2 listed)
- not speaking French
- no access to the French social security
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 |
|---|---|---|
| Urine sampling | Other | Fathers, Mothers |
| Carry a GPS and BET | Other | Mothers |
| Carry pollution sensor | Other | Mothers |
| Sampling at the maternity | Other | Mothers |
| Self-questionnaires | Other | Fathers, Mothers |
| Sampling in partum periodMeconium and a strand of hair. | Other | Children |
Primary outcome
Clinical exam : biological sampling
Time frame: Up to one hour
Sampling of : meconium, strands of hair, mouth cells, nose cells and a skin test in g
Clinical exam : biological sampling
Time frame: Up to one hour
Sampling of : urines, blood in mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Background: PubMed 2495113Barker DJ, Osmond C, Golding J, Kuh D, Wadsworth ME. Growth in utero, blood pressure in childhood and adult life, and mortality from cardiovascular disease. BMJ. 1989 Mar 4;298(6673):564-7. doi: 10.1136/bmj.298.6673.564.
- Background: PubMed 2570282Barker DJ, Winter PD, Osmond C, Margetts B, Simmonds SJ. Weight in infancy and death from ischaemic heart disease. Lancet. 1989 Sep 9;2(8663):577-80. doi: 10.1016/s0140-6736(89)90710-1.
- Background: PubMed 15640511Barker DJ. The developmental origins of adult disease. J Am Coll Nutr. 2004 Dec;23(6 Suppl):588S-595S. doi: 10.1080/07315724.2004.10719428.
- Background: PubMed 16055617Lawlor DA, Ebrahim S, Davey Smith G. Association of birth weight with adult lung function: findings from the British Women's Heart and Health Study and a meta-analysis. Thorax. 2005 Oct;60(10):851-8. doi: 10.1136/thx.2005.042408. Epub 2005 Jul 29.
- Background: PubMed 8490372Rona RJ, Gulliford MC, Chinn S. Effects of prematurity and intrauterine growth on respiratory health and lung function in childhood. BMJ. 1993 Mar 27;306(6881):817-20. doi: 10.1136/bmj.306.6881.817.
- Background: PubMed 7800004Martinez FD, Wright AL, Taussig LM, Holberg CJ, Halonen M, Morgan WJ. Asthma and wheezing in the first six years of life. The Group Health Medical Associates. N Engl J Med. 1995 Jan 19;332(3):133-8. doi: 10.1056/NEJM199501193320301.
- Background: PubMed 17050892Haland G, Carlsen KC, Sandvik L, Devulapalli CS, Munthe-Kaas MC, Pettersen M, Carlsen KH; ORAACLE. Reduced lung function at birth and the risk of asthma at 10 years of age. N Engl J Med. 2006 Oct 19;355(16):1682-9. doi: 10.1056/NEJMoa052885.
- Background: PubMed 17765525Stern DA, Morgan WJ, Wright AL, Guerra S, Martinez FD. Poor airway function in early infancy and lung function by age 22 years: a non-selective longitudinal cohort study. Lancet. 2007 Sep 1;370(9589):758-64. doi: 10.1016/S0140-6736(07)61379-8.
- Background: PubMed 14693659Jensen TK, Jorgensen N, Punab M, Haugen TB, Suominen J, Zilaitiene B, Horte A, Andersen AG, Carlsen E, Magnus O, Matulevicius V, Nermoen I, Vierula M, Keiding N, Toppari J, Skakkebaek NE. Association of in utero exposure to maternal smoking with reduced semen quality and testis size in adulthood: a cross-sectional study of 1,770 young men from the general population in five European countries. Am J Epidemiol. 2004 Jan 1;159(1):49-58. doi: 10.1093/aje/kwh002.
- Background: PubMed 16484675Moshammer H, Hoek G, Luttmann-Gibson H, Neuberger MA, Antova T, Gehring U, Hruba F, Pattenden S, Rudnai P, Slachtova H, Zlotkowska R, Fletcher T. Parental smoking and lung function in children: an international study. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1255-63. doi: 10.1164/rccm.200510-1552OC. Epub 2006 Feb 16.
- Background: PubMed 11799364McKeever TM, Lewis SA, Smith C, Collins J, Heatlie H, Frischer M, Hubbard R. Early exposure to infections and antibiotics and the incidence of allergic disease: a birth cohort study with the West Midlands General Practice Research Database. J Allergy Clin Immunol. 2002 Jan;109(1):43-50. doi: 10.1067/mai.2002.121016.
- Background: PubMed 15821200Li YF, Langholz B, Salam MT, Gilliland FD. Maternal and grandmaternal smoking patterns are associated with early childhood asthma. Chest. 2005 Apr;127(4):1232-41. doi: 10.1378/chest.127.4.1232.
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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.
iSABELLE Pin, MD principal investigator
University Hospital, Grenoble
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 Healthy Volunteer, run by University Hospital, Grenoble at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 27 Dec 2019. 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 France. 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?
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?
Clinical exam : biological sampling (time frame: Up to one hour). The study lists 2 primary outcomes in all. 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 NCT02852499, which also lists 38 linked publications.
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 27 Dec 2019.