Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04715945 |
| Other study ID # |
276/97 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 6, 1998 |
| Est. completion date |
December 31, 2028 |
Study information
| Verified date |
November 2023 |
| Source |
University of Southampton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
