Southampton Women's Survey

NCT ID: NCT04715945

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

12583 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-04-06

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Child Development Child Obesity Child Behavior Nutritional and Metabolic Diseases Asthma in Children Cardiovascular Risk Factor Bone Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women

12,583 women recruited when non-pregnant

No interventions assigned to this group

Children

3,158 liveborn singleton offspring of women recruited to the study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Not pregnant, resident in Southampton UK.

Exclusion Criteria

* GP requested no contact
Minimum Eligible Age

20 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cyrus Cooper, FMedSci

Role: STUDY_DIRECTOR

University of Southampton

References

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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.

Reference Type RESULT
PMID: 16195252 (View on PubMed)

El-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.

Reference Type DERIVED
PMID: 40714954 (View on PubMed)

Simpson 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.

Reference Type DERIVED
PMID: 36383511 (View on PubMed)

Other Identifiers

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276/97

Identifier Type: -

Identifier Source: org_study_id