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Investigating the use of biomarkers to predict pregnancy and long term complications in women who develop elevated blood pressure, gestational diabetes, fetal growth restriction or spontaneous preterm labour during pregnancy

Investigating the use of biomarkers to predict pregnancy and long term cardiovascular complications in women who develop elevated blood pressure, gestational diabetes, fetal growth restriction or spontaneous preterm labour during pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001450707
Acronym
BIOPIC
Enrollment
1
Registered
2022-11-14
Start date
2022-10-03
Completion date
2024-10-03
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Purpose of study: In Australia, up to 1 in 20 women will have a pregnancy impacted by pre-eclampsia, however recent changes to the definition of high blood pressure may assist in finding women most at risk earlier in their pregnancy. This study will explore a new approach to diagnosing pre-eclampsia that could benefit women in the future. Similarly, a third of women are affected by cardio-metabolic conditions during pregnancy such as gestational diabetes (GDM), pregnancy induced hypertension, pre-eclampsia, fetal growth restriction and spontaneous preterm birth. These conditions not only cause significant morbidity during pregnancy but are also associated with increased risk of maternal Type 2 Diabetes and Cardiovascular Disease (CVD) after pregnancy. However, CVD risk prediction tools do not capture these pregnancy-related cardio-metabolic conditions. Younger women and their health professionals have a limited understanding of the risks and screening and prevention are generally lacking. We know that these risks can be reduced by preventative screening (such as early screening for diabetes, abnormal lipid levels or elevated blood pressure) and optimising lifestyle strategies. This study offers an important opportunity to identify and target these women at risk for early intervention and screening. Hypothesis: Biological markers of endothelial, placental, inflammatory and cardiac dysfunction can be used to create an algorithm that can better predict the risk of developing pre-eclampsia, as well as risk of long-term cardiovascular sequelae in patients affected by pregnancy complications. Evidenced by derangement in cardio-metabolic markers following development of these conditions which persists post-delivery. Study design: Prospective observational trial involving two blood collection during pregnancy as well as after delivery. Where possible these blood test would be performed at time of routine pathology collection. Blood test result of patient who develops complication and those who does not is compared to develop an algorithm for prediction and diagnosis of pregnancy complications, as well as evaluate risk of long term cardiovascular complications. This study is observational only and does not interfere with routine antenatal care.

Interventions

This observational study does not include any intervention to routine medical care of the participant. Participation will involve completion of a questionnaire and collection of 3 blood samples. The questionnaire will have questions regarding basic demographic information, past medical history, details of previous pregnancy/pregnancies (gestational age at delivery, complications during pregnancy, any antenatal interventions, mode of delivery and birth weight), as well as details of current preg

This observational study does not include any intervention to routine medical care of the participant. Participation will involve completion of a questionnaire and collection of 3 blood samples. The questionnaire will have questions regarding basic demographic information, past medical history, details of previous pregnancy/pregnancies (gestational age at delivery, complications during pregnancy, any antenatal interventions, mode of delivery and birth weight), as well as details of current pregnancy (pregnancy complications, antenatal interventions). This will take 10-15min to complete. Blood samples will be collected once at time of recruitment, once at development of complications or at 36 weeks gestations, and finally at 6 months post birth. For this study we will also be collecting de-identified data from participant's medical records. This include demographic details, past medical history, antenatal complications, antenatal interventions, mode of delivery and any peri-partum complications. The total observational period will be from time of recruitment (at any gestation of pregnancy) until 6 months post delivery.

Sponsors

National Heart Foundation
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

1. Pregnant women at any gestation in pregnancy AND 2. Women who develop elevated blood pressure >130/80 OR 3. Women who have developed pregnancy complications (Gestational diabetes (GDM), Hypertensive disorder of pregnancy (HDP), Fetal growth restriction(FGR) and spontaneous preterm birth(sPTB))

Exclusion criteria

1. Multiple pregnancy. 2. Pregnancy complicated by major fetal anomaly or genetic syndrome. 3. Maternal age less than 18 years, 4. Women incapable of giving valid consent (diminished understanding, non-English speaking and interpreter unavailable). 5. Participation in a study where there is a pharmaceutical intervention that would likely modify the biomarkers under study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026