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

Not Applicable

Completed

• Conditions: pre eclampsia; placental insufficiency; intrauterine growth restriction; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12620001186943
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Study Completion: 2021-10-04
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Age 18 and over.
Ability to perform informed consent.
Singleton live intra-uterine pregnancy at admission to trial.
20+0 to 36+6 weeks gestation.
Clinical suspicion of placental insufficiency (preeclampsia and / or fetal growth restriction).

Exclusion Criteria

Known fetal chromosomal abnormality.
Known major fetal congenital abnormality.
Multiple pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median sFlt-1/PlGF ratio in New Zealand women with and without placental insufficiency by ethnicity. This will be assessed by blood sample.[At recruitment, <34 weeks gestation, 34+0 to 36+6 weeks gestation, and 37+ weeks gestation. ];The predictive value of a sFlt-1/PlGF ratio cut-point of 38, in women less than 35+0 weeks gestation, to predict birth within 14 days. The sFlt-1/PlGF ratio is determined by blood test.. [Birth]

Secondary Outcome Measures

Name	Time	Method
Economic analysis: would knowing the test result have reduced cost. <br><br>Outcome measured by the calculating the difference between resource used, collected from hospital medical records, [3 months after the birth date.];The predictive value of a sFlt-1/PlGF ratio cut-off of 38, in women less than 37+0 weeks gestation, to rule out preeclampsia within 1 week and to rule in preeclampsia within 4 weeks of the baseline visit, The sFlt-1/PlGF ratio is determined by blood test.. [At 1 and 4 weeks after the baseline visit]