Landspitali - University Hospital
Landspítali and University of Iceland Research Institute for Obstetrics, Gynecology, Child and Family Studies (RKB)
Prediction of placental insufficiency
Planning has begun for a study aimed at finding better methods to predict serious pregnancy and childbirth complications caused by placental dysfunction, so-called placental insufficiency.
The principal investigator of the study is Jóhanna Gunnarsdóttir, Head of the Education and Research Division of Obstetrics and Gynecology at Landspítali and the University of Iceland.
Information about the study
Principal Investigator:
Dr. Jóhanna Gunnarsdóttir, Obstetrician and Gynecologist at Landspítali and Associate Professor at University of Iceland,
Head of the Academic Department of Obstetrics and Gynecology.
Other researchers:
Dr. Alexander Smárason, Chief Physician in Obstetrics and Gynecology at Akureyri Hospital and Professor at the Health Sciences Institute of Akureyri Hospital and University of Akureyri.
Dr. Brynhildur Tinna Birgisdóttir, Obstetrician and Gynecologist at Landspítali and researcher at Karolinska Institutet in Stockholm.
Dr. Emma Marie Swift, Midwife at Reykjavík Birth Center and Associate Professor at University of Iceland.
• Dr. Hulda Hjartardóttir, Chief Physician of the Maternity Team at Landspítali and Lecturer at the Faculty of Medicine, University of Iceland.Dr. Jón Jóhannes Jónsson, Chief Physician of the Department of Genetics and Molecular Medicine at Landspítali and Professor of Biochemistry at the Faculty of Medicine, University of Iceland.
Ragnheiður Backmann, Midwife at Primary Health Care of the Capital Area and at the Development Centre for Icelandic Primary Healthcare.
Ragnheiður I. Bjarnadóttir, Obstetrician and Gynecologist at Landspítali and Lecturer at University of Iceland.
Þóra Steffensen, Specialist in Placental Pathology at Landspítali and Tampa General Hospital.
The aim of the study is to identify better methods for predicting placental insufficiency. It is hoped that the study may lead to new ways of preventing the serious consequences of placental insufficiency.
You are under no obligation to participate in the study. If you choose to participate, you will be asked to provide written informed consent during your 12-week ultrasound appointment, confirming that you understand the purpose of the study. Participation in the study involves providing blood samples, which may result in bruising, but the risk is otherwise considered negligible. You will also be asked to grant the researchers access to information regarding your health, pregnancy outcome, and delivery outcome from medical records and databases. By participating, you give the researchers permission to store your biological samples and health information permanently at Landspítali. No compensation will be provided for participation in the study.
In brief, participants will be asked to do the following, in chronological order:
12 weeks:
Provide an additional blood sample at the same time as routine blood sampling during antenatal care.
16 weeks:
Answer a few questions regarding physical activity and the use of Hjartamagnýl (if applicable).
36 weeks:
Provide a second blood sample for the study, in addition to routine antenatal care sampling.
After delivery:
Allow examination of the placenta at the Department of Pathology at
Landspítali
and provide a sample from the placenta.
Below are answers to some questions you may have. You may contact the principal investigator by email to express your interest in receiving further information without committing to participation in the study: johagunn@landspitali.is .
Questions and answers for study participants
Placental insufficiency can lead to the mother developing preeclampsia and to impaired fetal growth. In the most severe cases, the condition can become life-threatening for the mother and/or the baby. Although both the mother and the unborn child are closely monitored during pregnancy, placental insufficiency cannot currently be diagnosed until its consequences become apparent and the placenta is examined after delivery.
Preventing complications depends on being able to detect placental insufficiency during pregnancy. For this reason, we aim to identify substances in maternal blood that may indicate placental insufficiency. In this way, we hope to diagnose placental insufficiency during pregnancy and subsequently provide appropriate monitoring and treatment.
Blood and placental samples will be labeled with a coded identifier rather than a national ID number and stored at Landspítali in an appropriate biobank for biological samples.
Protein levels in maternal blood will be measured, including some proteins originating from the placenta. Some analyses will be carried out abroad by collaborating partners, who will destroy any remaining sample material once the specified substances have been measured.
The purpose of storing the samples permanently is to enable the measurement of other substances in the future that are currently unknown or cannot yet be measured, but which may later prove important in predicting complications during pregnancy or childbirth. If a proposal arises to measure specific substances, approval must first be obtained from the National Bioethics Committee to ensure that the procedures comply with scientific and ethical standards.
You can access information about analyses performed on the biological samples you provide on this page.
After delivery, a decision is normally made as to whether a pathological examination of the placenta may be useful for planning monitoring in future pregnancies, based on specific clinical guidelines. If you participate in this research study, your placenta will be examined regardless of this assessment. However, you will only receive information about the results if current clinical practice recommends placental examination following delivery.
When applicable, physicians within the research team will ensure that participants receive information about the results of the placental examination no later than approximately six months after delivery.
In most cases, analyses of the samples will be performed after you have delivered your baby. You will not receive information about the measured values from your own samples, but you will be able to access information on this page about research results for the participant group as a whole.
The first substance to be measured from the 12-week samples is a placental protein called Placental Growth Factor. In some countries, this protein is measured and used to help predict early-onset preeclampsia, but its usefulness has not yet been evaluated in Iceland.
Yes, you may change your mind and withdraw from the study at any time without this affecting the healthcare services that you or your child receive. If you decide to withdraw, your information and biological samples will be destroyed. However, if the study results have already been published, it will not be possible to delete the data on which the published results were based, although it will no longer be possible to trace the data back to you.
Research results will be published without personal identifiers and will always be presented for groups of participants rather than for individuals. During data collection, personally identifiable information will be processed in order to verify the accuracy of recorded information and for linkage with other databases. Personal identifiers will be transferred securely to institutions such as the Directorate of Health. Biological samples will be stored using coded identifiers rather than national ID numbers.
Once data collection has been completed, only coded biological samples and health information will be used. The code key linking the coded identifier to your national ID number will be securely stored within Landspítali and will only be accessible to the principal investigator of the study and their designated deputy.