Child DevelopmentSWSNCT04715945
Southampton Women's Survey
An observational study of Child Development and Child Obesity, run by University of Southampton.
Trial summary
The Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Obesity, Child Behavior
- How many people
- 12,583 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 1998to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All non-pregnant women in the correct age group living in Southampton between 1998 and 2002 were eligible.
Who may be able to join
- Not pregnant, resident in Southampton UK.
Who cannot join
- GP requested no contact
About this study
Official title: Southampton Women's Survey - a Study of Non-pregnant Women and Follow-up of Offspring Through Pregnancy and Childhood
The Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited, and 3,158 were followed through pregnancy, with their offspring followed-up at 6 months and 1, 2, 3, 4, 6-7, 8-9 and 12-13 years. The 17-19 year follow-up has been piloted and is about to start.
Read the detailed description
The Southampton Women's Survey (SWS) was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited and the subsequent offspring of 3158 of them are being followed-up. Few other longitudinal studies of children have data on the tempo of prenatal growth, and none in high-income countries has information recorded before pregnancy.
The objectives of the SWS are: (a) to characterise the influences of a mother's own fetal growth and of her dietary balance, body composition and endocrine profile before and during pregnancy on (i) the early trajectory of fetal growth; (ii) the maintenance of this growth trajectory in late gestation; and (iii) placental and fetal adaptive responses, (b) to examine how maternal and intrauterine influences interact with the offspring's genes and postnatal environment to determine: (i) weight gain and linear catch-up growth in infancy; (ii) the pathways of growth and development during childhood that lead to poor adult health (obesity, obstructive airways disease, cardiovascular disease, diabetes, and osteoporosis).
Between 1998 and 2002, 12,583 women aged 20 to 34 years were interviewed and their diet, body composition, physical activity levels, lifestyles and social circumstances were assessed. Blood, urine and mouthwash samples were collected for genetic and other analyses. Women who subsequently became pregnant were followed-up at 11, 19 and 34 weeks' gestation and fetal ultrasound scans were performed to obtain longitudinal measurements of fetal growth during pregnancy. Between 1998 and 2007, 3,158 women delivered a single live born infant. Biological samples were taken and anthropometric measurements of the baby were made within 48 hours of birth. In a sample of 1,000 children, dual-energy X-ray absorptiometry (DXA) was performed in the first two weeks of life.
The children were followed up at ages 6, 12, 24 and 36 months. A variety of assessments were made at the different follow-up interviews including breastfeeding, diet, anthropometry, and illnesses. At 24 months, the social circumstances of the family were assessed and, at 36 months, parenting, and emotional and behavioural issues were recorded. Subsequently, samples of the cohort have been seen at specific ages; at 4 years approximately 1,000 cohort participants; at 6-7 years approximately 2,000, and at 8-9 years approximately 1,000. At each time point from 4 years, body composition and bone indices were assessed using DXA; at 4 years, cognitive function was measured, at 6-7 years the focus was respiratory health and cognitive function, and at 8-9 years cardiovascular structure and function. Over 1000 child have been seen at age 12-13 years and the visits at 17-19 years of age have been piloted and are about to start with a focus on preparation for parenthood. Furthermore, plans are being developed to follow up the 12,583 women originally recruited to the SWS to assess the influence of their younger adult lifestyles, body composition and hormones on their transition through the menopause.
- Conditions
- Child Development, Child Obesity, Child Behavior, Nutritional and Metabolic Diseases, Asthma in Children, Cardiovascular Risk Factor
- Medical subject headings
- Pediatric Obesity, Child Behavior, Nutritional and Metabolic Diseases, Bone Diseases, Metabolic
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 |
|---|---|---|
| Women | 12,583 women recruited when non-pregnant | |
| Children | 3,158 liveborn singleton offspring of women recruited to the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child health and development
Child health and development from birth to 19 years, focussing on body composition, nutrition, asthma and cardiovascular health
Measured: 0 - 19 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start6 Apr 1998
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child 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
- 12,583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrus Cooper, FMedSci, Study director, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715945
- Sponsor's protocol ID
- 276/97
- Acronym
- SWS
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data can be shared subject to approval of SWS oversight group and completion of confidentiality agreements.
Publications
Inskip HM, Godfrey KM, Robinson SM, Law CM, Barker DJ, Cooper C; SWS Study Group. Cohort profile: The Southampton Women's Survey. Int J Epidemiol. 2006 Feb;35(1):42-8. doi: 10.1093/ije/dyi202. Epub 2005 Sep 29. No abstract available.
PubMed 16195252El-Heis S, Crozier SR, Loo EX, Tham EH, Harvey NC, Inskip HM; Southampton Women's Survey Study Group; Godfrey KM. Maternal Dietary Inflammatory Status and Serum Neopterin During Pregnancy: Influence on Infantile Atopic Eczema in the Offspring. Clin Transl Allergy. 2025 Jul;15(7):e70080. doi: 10.1002/clt2.70080.
PubMed 40714954Simpson RF, Hesketh KR, Crozier SR, Baird J, Cooper C, Godfrey KM, Harvey NC, Westgate K, Inskip HM, van Sluijs EMF. The association between number and ages of children and the physical activity of mothers: Cross-sectional analyses from the Southampton Women's Survey. PLoS One. 2022 Nov 16;17(11):e0276964. doi: 10.1371/journal.pone.0276964. eCollection 2022.
PubMed 36383511
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southampton Women's Survey - a Study of Non-pregnant Women and Follow-up of Offspring Through Pregnancy and Childhood
- ClinicalTrials.gov ID
- NCT04715945
- Acronym / sponsor ID
- SWS / 276/97
- Conditions
- Child Development, Child Obesity, Child Behavior, Nutritional and Metabolic Diseases, Asthma in Children, Cardiovascular Risk Factor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,583 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 6 Apr 1998 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Jan 2021 (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 Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited, and 3,158 were followed through pregnancy, with their offspring followed-up at 6 months and 1, 2, 3, 4, 6-7, 8-9 and 12-13 years. The 17-19 year follow-up has been piloted and is about to start.
Detailed description
The Southampton Women's Survey (SWS) was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited and the subsequent offspring of 3158 of them are being followed-up. Few other longitudinal studies of children have data on the tempo of prenatal growth, and none in high-income countries has information recorded before pregnancy.
The objectives of the SWS are: (a) to characterise the influences of a mother's own fetal growth and of her dietary balance, body composition and endocrine profile before and during pregnancy on (i) the early trajectory of fetal growth; (ii) the maintenance of this growth trajectory in late gestation; and (iii) placental and fetal adaptive responses, (b) to examine how maternal and intrauterine influences interact with the offspring's genes and postnatal environment to determine: (i) weight gain and linear catch-up growth in infancy; (ii) the pathways of growth and development during childhood that lead to poor adult health (obesity, obstructive airways disease, cardiovascular disease, diabetes, and osteoporosis).
Between 1998 and 2002, 12,583 women aged 20 to 34 years were interviewed and their diet, body composition, physical activity levels, lifestyles and social circumstances were assessed. Blood, urine and mouthwash samples were collected for genetic and other analyses. Women who subsequently became pregnant were followed-up at 11, 19 and 34 weeks' gestation and fetal ultrasound scans were performed to obtain longitudinal measurements of fetal growth during pregnancy. Between 1998 and 2007, 3,158 women delivered a single live born infant. Biological samples were taken and anthropometric measurements of the baby were made within 48 hours of birth. In a sample of 1,000 children, dual-energy X-ray absorptiometry (DXA) was performed in the first two weeks of life.
The children were followed up at ages 6, 12, 24 and 36 months. A variety of assessments were made at the different follow-up interviews including breastfeeding, diet, anthropometry, and illnesses. At 24 months, the social circumstances of the family were assessed and, at 36 months, parenting, and emotional and behavioural issues were recorded. Subsequently, samples of the cohort have been seen at specific ages; at 4 years approximately 1,000 cohort participants; at 6-7 years approximately 2,000, and at 8-9 years approximately 1,000. At each time point from 4 years, body composition and bone indices were assessed using DXA; at 4 years, cognitive function was measured, at 6-7 years the focus was respiratory health and cognitive function, and at 8-9 years cardiovascular structure and function. Over 1000 child have been seen at age 12-13 years and the visits at 17-19 years of age have been piloted and are about to start with a focus on preparation for parenthood. Furthermore, plans are being developed to follow up the 12,583 women originally recruited to the SWS to assess the influence of their younger adult lifestyles, body composition and hormones on their transition through the menopause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | – | –12,583 women recruited when non-pregnant |
| Children | – | –3,158 liveborn singleton offspring of women recruited to the study |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All non-pregnant women in the correct age group living in Southampton between 1998 and 2002 were eligible.
Key inclusion criteria (1 listed)
- Not pregnant, resident in Southampton UK.
Key exclusion criteria (1 listed)
- GP requested no contact
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
Child health and development
Time frame: 0 - 19 years
Child health and development from birth to 19 years, focussing on body composition, nutrition, asthma and cardiovascular health
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 16195252Inskip HM, Godfrey KM, Robinson SM, Law CM, Barker DJ, Cooper C; SWS Study Group. Cohort profile: The Southampton Women's Survey. Int J Epidemiol. 2006 Feb;35(1):42-8. doi: 10.1093/ije/dyi202. Epub 2005 Sep 29. No abstract available.
- Derived from this study: PubMed 40714954El-Heis S, Crozier SR, Loo EX, Tham EH, Harvey NC, Inskip HM; Southampton Women's Survey Study Group; Godfrey KM. Maternal Dietary Inflammatory Status and Serum Neopterin During Pregnancy: Influence on Infantile Atopic Eczema in the Offspring. Clin Transl Allergy. 2025 Jul;15(7):e70080. doi: 10.1002/clt2.70080.
- Derived from this study: PubMed 36383511Simpson RF, Hesketh KR, Crozier SR, Baird J, Cooper C, Godfrey KM, Harvey NC, Westgate K, Inskip HM, van Sluijs EMF. The association between number and ages of children and the physical activity of mothers: Cross-sectional analyses from the Southampton Women's Survey. PLoS One. 2022 Nov 16;17(11):e0276964. doi: 10.1371/journal.pone.0276964. eCollection 2022.
- Individual participant dataSharing planned: Yes. All data can be shared subject to approval of SWS oversight group and completion of confidentiality agreements.
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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.
Cyrus Cooper, FMedSci study director
University of Southampton
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Child Obesity, run by University of Southampton.
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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Child health and development (time frame: 0 - 19 years). 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 NCT04715945, which also lists 3 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 8 May 2026.