NCT04666285

Brief Summary

The current COVID-19 pandemic has brought many challenges with implications for wellbeing and mental health. The Southampton Women's Survey provides the opportunity to understand influences on these important outcomes amongst women and their offspring in the context of an established longitudinal cohort study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 15, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

October 15, 2020

Last Update Submit

October 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mental Health in women

    General Health Questionnaire (GHQ-12) - higher score more severe condition

    3 months

Secondary Outcomes (1)

  • Mental Health in offspring

    3 months

Interventions

Experience of the pandemic will be studied through online questionnaire responses

Eligibility Criteria

Age12 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Between 1998 and 2002 the Southampton Women's Survey team interviewed 12,583 Southampton women aged 20 to 34 years. Of these participants, 3,158 women subsequently became pregnant within the study period and delivered a liveborn singleton infant.

You may qualify if:

  • Women with offspring born in the Southampton Women's Survey (original project)
  • Offspring born in the Southampton Women's Survey (original project)

You may not qualify if:

  • anyone who was not a part of the original project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC Lifecourse Epidemiology Unit

Southampton, SO16 6YD, United Kingdom

Location

Study Officials

  • Keith Godfrey, BM, PhD,FRCP

    Professor of Human Development and Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 15, 2020

First Posted

December 14, 2020

Study Start

February 15, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

October 4, 2021

Record last verified: 2021-10

Locations