SPRING:? Southampton pregnancy intervention for the next generatio

Not Applicable

Suspended

• Conditions: Musculoskeletal; Pregnancy and Childbirth

• Registration Number: ISRCTN07227232
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27729061

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-12
• Last Update Posted: 18 May 2020
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: Suspended
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

Women attending the Princess Anne Hospital for nuchal lucency or dating scans in early pregnancy

Exclusion Criteria

1. Women under the age of 18
2. Living outside a Southampton postcode area
3. Multiple pregnancy
4. Severely unwell
5. Allergic to peanuts or soya
6. Involved in another research study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 15/06/2018:<br> 1. Maternal circulating plasma 25(OH) vitamin D concentration at 34 weeks’ gestation<br> 2. Maternal diet quality at 34 weeks’ gestation assessed with a 20-item food frequency questionnaire<br><br> Previous primary outcome measures as of 30/05/2018:<br> 1. Maternal circulating plasma 25(OH) vitamin D concentration at 34 weeks<br> 2. Maternal diet quality at 34 weeks gestation assessed with a 20-item food frequency questionnaire<br><br> Previous primary outcome measures:<br> 1. Vitamin D status of mother measured by assay at baseline and again at 34 weeks of pregnancy<br> 2. Body composition of infants at birth measured by DXA scan<br>