Screening programme for pre-eclampsia

Not Applicable

Completed

• Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine; Pregnancy and Childbirth; Pre-eclampsia

• Registration Number: ISRCTN83611527
• Lead Sponsor: Delegated to University College London Comprehensive Clinical Trials Unit (UCL CCTU) by Kings College London

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28295773 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29536574 results 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33226739/ (added 18/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-06
• Study Completion: 2018-07-31
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 16747

Inclusion Criteria

1. Aged 18 years or over
2. Singleton pregnancy
3. Live fetus at 11-13 weeks' gestation
4. Informed and written consent

Exclusion Criteria

1. Women who are severely ill
2. Those with learning difficulties
3. Those with a serious mental illness
4. Pregnancies complicated by major fetal abnormality identified at 11-13 weeks of gestation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy (false positive and true positive frequencies) of screening for pre-eclampsia using the Bayes theorem based method is measured as the rate of pre-eclampsia, determined using medical note review within one month of birth.

Secondary Outcome Measures

Name	Time	Method
Detection rate of pre-eclampsia is measured through medical note review within one month of birth.