SWS: Southampton Women's Survey

Sponsor
University of Southampton (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04715945
Collaborator
(none)
12,583
368.9

Study Details

Study Description

Brief 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. 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

Study Type:
Observational
Actual Enrollment :
12583 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Southampton Women's Survey - a Study of Non-pregnant Women and Follow-up of Offspring Through Pregnancy and Childhood
Actual Study Start Date :
Apr 6, 1998
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Women

12,583 women recruited when non-pregnant

Children

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

Outcome Measures

Primary Outcome Measures

  1. Child health and development [0 - 19 years]

    Child health and development from birth to 19 years, focussing on body composition, nutrition, asthma and cardiovascular health

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 34 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Not pregnant, resident in Southampton UK.
Exclusion Criteria:
  • GP requested no contact

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Southampton

Investigators

  • Study Director: Cyrus Cooper, FMedSci, University of Southampton

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southampton
ClinicalTrials.gov Identifier:
NCT04715945
Other Study ID Numbers:
  • 276/97
First Posted:
Jan 20, 2021
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022