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Åse Turid Rossevatn Svoren
Senior Consultant
aseThe PRERISK study is being conducted at the Departments of Obstetrics and Gynaecology at Ålesund Hospital and St. Olavs Hospital. The study will compare women in their first pregnancy who have either a low or an increased risk of developing preeclampsia.
What does participation in the study involve?
Assessment of preeclampsia risk
If you wish to participate, an additional blood flow measurement of the uterine arteries using Doppler ultrasound will be performed during your routine early pregnancy ultrasound examination between gestational weeks 11 and 14. We will also measure your blood pressure, ask about known risk factors for preeclampsia, and collect a blood sample.
This information will be used to calculate your risk of developing preeclampsia. Within one week, a physician will review the results, and approximately one-fifth of participants will be invited for further assessments as part of the study. Those invited will either have a low or an increased risk of developing the condition. Both groups will receive the same close follow-up throughout pregnancy.
Even if you are not contacted for further participation, you will still have contributed valuable knowledge about the assessment of preeclampsia risk in early pregnancy.
At study enrolment (gestational weeks 11–14)
If you agree to participate, blood and urine samples will be collected at enrolment.
Follow-up during pregnancy
You will be closely monitored throughout your pregnancy with ultrasound examinations at gestational weeks 22–24, 32, and 36. During these visits, we will assess foetal growth and well-being and measure blood flow in the uterine arteries using Doppler ultrasound.
Your blood pressure will be checked at every visit, you will be asked about specific symptoms of preeclampsia, and blood and urine samples will be collected. Each study visit, including sample collection, will take approximately one hour.
If the course of your pregnancy indicates a need for additional monitoring, further pregnancy check-ups will be arranged.
Sample collection after delivery
After the baby and placenta have been delivered, samples will be collected from the placenta, and blood will be taken from the umbilical cord. In addition, a blood sample and a urine sample will be collected from the mother six months after delivery.
Possible benefits and disadvantages
By participating in this study, you will contribute to important knowledge about preeclampsia, helping us to better understand, prevent, and treat this condition.
Women who are enrolled after the first ultrasound examination are identified as having either a low or an increased risk of developing preeclampsia. To avoid differences in management between the groups, neither you nor the healthcare professionals caring for you will be informed whether you are in the low-risk or increased-risk group. Therefore, all participants will receive closer follow-up, including at least three additional visits in specialist healthcare services.
It is important to be aware that most women identified as having an increased risk of preeclampsia do not develop the condition. Furthermore, among those who do develop preeclampsia, the condition is usually mild and most often occurs late in pregnancy.
Participation in the study involves three additional ultrasound examinations during gestational weeks 22–24, 32, and 36. All examinations are performed using an ultrasound probe placed on the abdomen (not vaginally). The ultrasound examinations used in this study are considered safe and will not harm you or your baby.
Voluntary participation and the right to withdraw consent
Participation in this study is voluntary. If you choose to provide your consent, you may at any time request information about what material has been collected from you, how it has been used, and the results that have emerged from the research. Your decision whether or not to participate will have no impact on any further treatment you receive at the hospital.
If you wish to withdraw your consent, you may contact the undersigned at any time to have your samples and data removed and destroyed, without having to provide any reason for doing so.
What will happen to your information and samples?
During the study, we will collect health information about you and, if necessary, obtain relevant information from your medical records. This may include information about your health status, previous illnesses, medication use, blood flow and blood pressure measurements, and the results of blood and urine tests.
The health information and biological samples collected from you (including blood, urine, umbilical cord blood, and placental tissue) will form part of the PRERISK study and will be managed by Biobank1, the regional research biobank of Central Norway Regional Health Authority.
The biological samples will be analysed to investigate biological differences between pregnancies with low and increased risk of preeclampsia, such as differences in immune signalling and lipid profiles. Most of the research will be conducted in Norway. In some cases, it may be necessary to transfer biological material, research results, and/or health information abroad for analysis. Any such transfer will take place without directly identifiable personal information.
The information recorded about you will only be used for the purposes described in this research project and is planned to be used until 2032. Any extension of the use or storage period will require approval from the Regional Committee for Medical and Health Research Ethics (REK) and other relevant authorities.
You have the right to access the information that has been recorded about you and to request correction of any inaccuracies. You also have the right to obtain information about the security measures used to protect your data. In addition, you may lodge a complaint regarding the processing of your personal data with the Norwegian Data Protection Authority and the institution’s Data Protection Officer.
All information will be processed without your name, personal identification number, or other directly identifiable information (that is, as coded data). A code will link you to your data through a separate list containing participants’ identities. Only the PhD research fellow Åse Turid Rossevatn Svoren and the project leader Ann-Charlotte Iversen will have access to this list.
After the research project has been completed, your information will be stored for five years for monitoring and regulatory purposes.
Insurance
Participants in the study will be covered by the Norwegian System of Patient Injury Compensation (NPE).
Approvals
The study has been reviewed and approved by the Regional Committee for Medical and Health Research Ethics (REK) (reference number 537602).
Data protection
Helse Møre og Romsdal is responsible for data protection in this study. Personal data will be processed in accordance with Article 6(1)(a) and Article 9(2)(j) of the EU General Data Protection Regulation (GDPR).
These legal provisions allow the processing of personal data based on your consent and for scientific research purposes, subject to appropriate safeguards for your rights and privacy.