NCT04715945

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,583

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Apr 1998

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Apr 1998Dec 2028

Study Start

First participant enrolled

April 6, 1998

Completed
22.8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

29.8 years

First QC Date

January 14, 2021

Last Update Submit

May 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Child health and development

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

    0 - 19 years

Study Arms (2)

Women

12,583 women recruited when non-pregnant

Children

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

Eligibility Criteria

Age20 Years - 34 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNon-pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All non-pregnant women in the correct age group living in Southampton between 1998 and 2002 were eligible.

You may qualify if:

  • Not pregnant, resident in Southampton UK.

You may not qualify if:

  • GP requested no contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, mouth swaps, umbilical cord, cord blood, placental samples

MeSH Terms

Conditions

Pediatric ObesityChild BehaviorNutritional and Metabolic DiseasesBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Study Officials

  • Cyrus Cooper, FMedSci

    University of Southampton

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 20, 2021

Study Start

April 6, 1998

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All data can be shared subject to approval of SWS oversight group and completion of confidentiality agreements.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Most data are already available and will continue to be available we hope beyond completion of the study.
Access Criteria
Application to SWS oversight group
More information