Assessing the use of pregnancy biomarkers (blood test) in women with pre-existing diabetes, to identify women at risk of placental insufficiency in order to optimise their antenatal care

Not Applicable

Recruiting

• Conditions: placental insufficiency; pre-eclampsia; fetal growth restriction; Type 1 diabetes; Type 2 diabetes; Reproductive Health and Childbirth - Antenatal care; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622001159741
• Lead Sponsor: Ruth Hughes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

•Age 18 and over
•Ability to provide informed consent
•Live pregnancy at admission to trial
•No current suspicion of placental insufficiency
•20+0 to 24+6 weeks gestation
•Type 1 or type 2 diabetes
; •Age 18 and over
•Ability to provide informed consent
•Live pregnancy at admission to trial
•No current suspicion of placental insufficiency
•20+0 to 24+6 weeks gestation
•Type 1 or type 2 diabetes

Exclusion Criteria

Placental insufficiency is already suspected and under investigation prior to recruitment. ; Placental insufficiency is already suspected and under investigation prior to recruitment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 36 weeks gestation. This will be assessed by blood sample.[ 36 weeks gestation. The outcome will be assessed retrospectively after the birth. ];To assess the prevalence of asymptomatic placental insufficiency in pregnancies complicated by type 1 or 2 diabetes as determined by a sFlt 1/PlGF ratio at 36 weeks gestation. This will be assessed by blood sample.[ 36 weeks gestation. The outcome will be assessed retrospectively after the birth. ]