None listed
Conditions
Brief summary
This is a small study to look at the potential benefits of introducing a blood test (SFlt/PlGF ratio) to screen for placental insufficiency in pregnant women with preexisting (type 1 or type 2) diabetes. Placental insufficiency (a placenta that is not working well) may lead to preeclampsia (high blood pressure) and / or fetal growth restriction (small baby) and affects one in ten pregnancies in New Zealand, but women with pre-existing diabetes have 2-4 times the risk. Placental insufficiency can be hard to detect and when doctors think that there may be a placental problem, women have extra hospital visits and tests to determine when it is safest for the baby to be born. The study blood test is called the SFlt/PlGF ratio and it measures two proteins that affect blood vessels in the placenta and in the mother's circulation. Previous studies have found that this test may help doctors to decide whether pregnant mothers with symptoms have placental insufficiency and guide their care. The blood test may be able to separate women who need to give birth early from those who don’t.. In this study we will be assessing the value of screening for placental insufficiency before there are symptoms or signs of disease, to identify mothers at greatest risk who may then require extra monitoring.
Interventions
Blood sampling for the SFlt/PLGF ratio at 4 weekly intervals from recruitment at 20-24 weeks gestation until 36 weeks gestation.
A 4ml study blood sample will be drawn by a practicing phlebotomist at the time the mother is recruited and subsequently at outpatient visits. Blood will be drawn when the mother attends her scheduled appointments at Christchurch Women's hospital at four weekly intervals until 36 weeks gestation.
No extra visits will be required for study purposes.
Strategies used to
Blood sampling for the SFlt/PLGF ratio at 4 weekly intervals from recruitment at 20-24 weeks gestation until 36 weeks gestation. A 4ml study blood sample will be drawn by a practicing phlebotomist at the time the mother is recruited and subsequently at outpatient visits. Blood will be drawn when the mother attends her scheduled appointments at Christchurch Women's hospital at four weekly intervals until 36 weeks gestation. No extra visits will be required for study purposes. Strategies used to monitor adherence to the intervention: checklists for the timing of blood samples will be placed in the front of the paper records for each participant and electronic reminders will be attached to outpatient schedules.
Sponsors
Ruth Hughes
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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
Exclusion criteria
Placental insufficiency is already suspected and under investigation prior to recruitment.
Outcome results
None listed