Intrauterine DevelopmentNCT01778205
The Reus-Tarragona Birth Cohort Study of Early Development and Ageing.
An observational study of Intrauterine Development, run by Institut Investigacio Sanitaria Pere Virgili at 2 sites in Spain.
Trial summary
The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Development
- What is being tested?
- Observational
- How many people
- 831 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2005to 14 Sep 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women less than 12 weeks pregnant at their first pre-natal check up are recruited from the URV University Hospitals: Sant Joan (Reus) and Joan XXIII (Tarragona)
Who may be able to join
- <12 weeks pregnant at first prenatal check up
Who cannot join
- Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201
Hospital de Tarragona Joan XXIII
Tarragona, 43005
About this study
Official title: Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.
The recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at <12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at <12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.
- Conditions
- Intrauterine Development
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women with confirmed viable fetus at first prenatal check-up at <12 gestational weeks Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Measured: At birth
Doppler waveforms of uterine arteries
Measured: 20 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2005
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intrauterine DevelopmentStudies 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
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Italfarmaco, Instituto de Salud Carlos III, State Research Agency, Spain, JPI ERA-HDHL, University Rovira i Virgili, European Regional Development Fund
- Responsible party
- Principal investigator, Dr. Michelle Murphy, Institut Investigacio Sanitaria Pere Virgili
- Investigators
- Michelle M Murphy, PhD, Principal investigator, University Rovira i VirgiliPere Cavallé-Busquets, MD, PHD, Study director, Hospital Universitari Sant Joan de ReusJoan D Fernandez-Ballart, PhD, Study chair, University Rovira i VirgiliMónica Ballesteros, MD, PHD, Study director, Hospital de Tarragona Joan XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778205
- Sponsor's protocol ID
- IISPV_Murphy1
- Other IDs
- SPAIN MICINN, SPAIN ISCIII, SPAIN URV, SPAIN ISCIII, SPAIN ISCIII, SPAIN AEI, Horizon 2020
- Status last verified
- Sep 2021
- First submitted
- 25 Jan 2013
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colomina JM, Cavalle-Busquets P, Fernandez-Roig S, Sole-Navais P, Fernandez-Ballart JD, Ballesteros M, Ueland PM, Meyer K, Murphy MM. Maternal Folate Status and the BHMT c.716G>A Polymorphism Affect the Betaine Dimethylglycine Pathway during Pregnancy. Nutrients. 2016 Oct 9;8(10):621. doi: 10.3390/nu8100621.
PubMed 27735840Sole-Navais P, Salat-Batlle J, Cavalle-Busquets P, Fernandez-Ballart J, Ueland PM, Ballesteros M, Ornosa-Martin G, Ingles-Puig M, Colomina JM, Murphy MM. Early pregnancy folate-cobalamin interactions and their effects on cobalamin status and hematologic variables throughout pregnancy. Am J Clin Nutr. 2018 Feb 1;107(2):173-182. doi: 10.1093/ajcn/nqx041.
PubMed 29529156Roige-Castellvi J, Murphy M, Hernandez-Martinez C, Sole-Navais P, Cavalle-Busquets P, Fernandez-Ballart J, Ballesteros M, Canals J. The effect of prenatal smoke exposure on child neuropsychological function: a prospective mother-child cohort study. J Reprod Infant Psychol. 2020 Feb;38(1):25-37. doi: 10.1080/02646838.2019.1580350. Epub 2019 Feb 19.
PubMed 30777448Cavalle-Busquets P, Ingles-Puig M, Fernandez-Ballart JD, Haro-Barcelo J, Rojas-Gomez A, Ramos-Rodriguez C, Ballesteros M, Meyer K, Ueland PM, Murphy MM. Moderately elevated first trimester fasting plasma total homocysteine is associated with increased probability of miscarriage. The Reus-Tarragona Birth Cohort Study. Biochimie. 2020 Jun;173:62-67. doi: 10.1016/j.biochi.2020.01.008. Epub 2020 Jan 18.
PubMed 31962182Fernandez-Roig S, Cavalle-Busquets P, Fernandez-Ballart JD, Ballesteros M, Berrocal-Zaragoza MI, Salat-Batlle J, Ueland PM, Murphy MM. Low folate status enhances pregnancy changes in plasma betaine and dimethylglycine concentrations and the association between betaine and homocysteine. Am J Clin Nutr. 2013 Jun;97(6):1252-9. doi: 10.3945/ajcn.112.054189. Epub 2013 Apr 17.
PubMed 23595875Santos-Calderon LA, Cavalle-Busquets P, Ramos-Rodriguez C, Grifoll C, Rojas-Gomez A, Ballesteros M, Ueland PM, Murphy MM. Folate and cobalamin status, indicators, modulators, interactions, and reference ranges from early pregnancy until birth: the Reus-Tarragona birth cohort study. Am J Clin Nutr. 2024 Nov;120(5):1269-1283. doi: 10.1016/j.ajcnut.2024.09.015. Epub 2024 Sep 24.
PubMed 39326699
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Effect of Maternal Nutritional Status on Placental Vascular Function, Fetal Growth and Intrauterine Growth Retardation.
- ClinicalTrials.gov ID
- NCT01778205
- Acronym / sponsor ID
- IISPV_Murphy1
- Conditions
- Intrauterine Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Collaborators
- Italfarmaco, Instituto de Salud Carlos III, State Research Agency, Spain, JPI ERA-HDHL, University Rovira i Virgili, European Regional Development Fund
- Study start
- Jan 2005
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 29 Jan 2013 (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 recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . The WHO reports the median age of the European population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. There is wide variability in the quality of health and well-being in the ageing population. Longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. There is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. Epigenetic imprinting occurs both in utero and during early postnatal development. Maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. Numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. To understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. The Reus and Tarragona Birth Cohort is a longitudinal study. In the first phase, blood is collected from pregnant women at <12, 15, 24-27 and 34 gestational weeks (GW) and at labor and from the cord. Detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at <12GW and at birth. Placental vascular function is assessed at 20 and 32 GW by analysis of Doppler waveforms of the uterine arteries. Data on pregnancy evolution and outcome are also recorded. The first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. The second phase of the study follows up the children at 7.5 years of age. Growth, exercise and nutritional habits as well as environment and cognitive development are assessed. The aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: ObservationalPregnant women with confirmed viable fetus at first prenatal check-up at <12 gestational weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women less than 12 weeks pregnant at their first pre-natal check up are recruited from the URV University Hospitals: Sant Joan (Reus) and Joan XXIII (Tarragona)
Key inclusion criteria (1 listed)
- <12 weeks pregnant at first prenatal check up
Key exclusion criteria (1 listed)
- Illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
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 |
|---|---|---|
| Observational | Other | Pregnant women |
Primary outcome
Birth weight
Time frame: At birth
Doppler waveforms of uterine arteries
Time frame: 20 gestational weeks
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 23 Sep 2021.
- Background: PubMed 27735840Colomina JM, Cavalle-Busquets P, Fernandez-Roig S, Sole-Navais P, Fernandez-Ballart JD, Ballesteros M, Ueland PM, Meyer K, Murphy MM. Maternal Folate Status and the BHMT c.716G>A Polymorphism Affect the Betaine Dimethylglycine Pathway during Pregnancy. Nutrients. 2016 Oct 9;8(10):621. doi: 10.3390/nu8100621.
- Background: PubMed 29529156Sole-Navais P, Salat-Batlle J, Cavalle-Busquets P, Fernandez-Ballart J, Ueland PM, Ballesteros M, Ornosa-Martin G, Ingles-Puig M, Colomina JM, Murphy MM. Early pregnancy folate-cobalamin interactions and their effects on cobalamin status and hematologic variables throughout pregnancy. Am J Clin Nutr. 2018 Feb 1;107(2):173-182. doi: 10.1093/ajcn/nqx041.
- Background: PubMed 30777448Roige-Castellvi J, Murphy M, Hernandez-Martinez C, Sole-Navais P, Cavalle-Busquets P, Fernandez-Ballart J, Ballesteros M, Canals J. The effect of prenatal smoke exposure on child neuropsychological function: a prospective mother-child cohort study. J Reprod Infant Psychol. 2020 Feb;38(1):25-37. doi: 10.1080/02646838.2019.1580350. Epub 2019 Feb 19.
- Background: PubMed 31962182Cavalle-Busquets P, Ingles-Puig M, Fernandez-Ballart JD, Haro-Barcelo J, Rojas-Gomez A, Ramos-Rodriguez C, Ballesteros M, Meyer K, Ueland PM, Murphy MM. Moderately elevated first trimester fasting plasma total homocysteine is associated with increased probability of miscarriage. The Reus-Tarragona Birth Cohort Study. Biochimie. 2020 Jun;173:62-67. doi: 10.1016/j.biochi.2020.01.008. Epub 2020 Jan 18.
- Results publication: PubMed 23595875Fernandez-Roig S, Cavalle-Busquets P, Fernandez-Ballart JD, Ballesteros M, Berrocal-Zaragoza MI, Salat-Batlle J, Ueland PM, Murphy MM. Low folate status enhances pregnancy changes in plasma betaine and dimethylglycine concentrations and the association between betaine and homocysteine. Am J Clin Nutr. 2013 Jun;97(6):1252-9. doi: 10.3945/ajcn.112.054189. Epub 2013 Apr 17.
- Derived from this study: PubMed 39326699Santos-Calderon LA, Cavalle-Busquets P, Ramos-Rodriguez C, Grifoll C, Rojas-Gomez A, Ballesteros M, Ueland PM, Murphy MM. Folate and cobalamin status, indicators, modulators, interactions, and reference ranges from early pregnancy until birth: the Reus-Tarragona birth cohort study. Am J Clin Nutr. 2024 Nov;120(5):1269-1283. doi: 10.1016/j.ajcnut.2024.09.015. Epub 2024 Sep 24.
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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.
Michelle M Murphy, PhD principal investigator
University Rovira i Virgili
Pere Cavallé-Busquets, MD, PHD study director
Hospital Universitari Sant Joan de Reus
Joan D Fernandez-Ballart, PhD study chair
University Rovira i Virgili
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Development, run by Institut Investigacio Sanitaria Pere Virgili at 2 sites in Spain.
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 1 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 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Birth weight (time frame: At birth). 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 NCT01778205, which also lists 6 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 23 Sep 2021.