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 guide the care of New Zealand women with suspected placental problems. 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. When doctors think that there may be a placental problem, women have extra hospital visits and tests. Placental insufficiency can be hard to detect and it can be difficult to work out 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. Studies in other countries have found that this test may help doctors to decide whether pregnant mothers 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. This study will look at the use of the SFlt/PlGF ratio blood test in New Zealand as we need to make sure this test works as well in our people/Tangata whenua. We want to find out if the blood test can help pregnant mothers at low risk of needing to birth early, by reducing the number of hospital visits, ultrasound scans and blood tests in women who do not need them. We also want to see if this blood test can help us detect the pregnant mothers at high risk of an early birth who need to be in hospital for monitoring. In the future the test may be introduced as standard care in New Zealand as it is in some other countries.
Interventions
Blood sampling for the SFlt/PLGF ratio at 1-4 weekly intervals from recruitment until birth.
A 4ml study blood sample will be drawn by a practicing phlebotomist or midwife at the time the mother is recruited and subsequently when other routine antenatal bloods are drawn during pregnancy until the day of birth, but no more frequently than once per week.
The blood samples will be drawn when the mother is assessed at Christchurch Women's hospital, either in an outpatient or inpatient setting
Blood sampling for the SFlt/PLGF ratio at 1-4 weekly intervals from recruitment until birth. A 4ml study blood sample will be drawn by a practicing phlebotomist or midwife at the time the mother is recruited and subsequently when other routine antenatal bloods are drawn during pregnancy until the day of birth, but no more frequently than once per week. The blood samples will be drawn when the mother is assessed at Christchurch Women's hospital, either in an outpatient or inpatient setting. No extra visits will be required for study purposes. The frequency of the study blood tests will be determined by the frequency of the mother's routine assessments and antenatal blood tests taken at Christchurch Women's Hospital. 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
University of Otago
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Outcome results
None listed