Since 2001, the Oslo Pregnancy Biobank at Oslo University Hospital, location Ullevål (the largest Obstetrics Dept. in Norway), has collected clinical maternal and fetal data and biological samples from over 800 pregnancies. Pregnant women give their informed consent to participate in research studies aiming at better understanding pregnancy complications such as preeclampsia, intrauterine growth restriction and gestational diabetes.
The research study is initiated and led by Professor Anne Cathrine Staff. The project is approved by National research ethical committee (REK Sør-Øst Norge) and by institution research bodies. The patients provide written informed consent to donate fasting maternal blood and fetal blood as well as amniotic fluid, placental and decidual tissue, subcutaneous fat and muscle biopsies during cesarean delivery that is scheduled independently of the research study.
This database includes clinical data that are coupled to the biological samples and test results, and the results are only published in non-identifiable forms on group basis. The biobank is unique owing to its comprehensiveness, stringent tissue sampling, detailed clinical data and pilot long-term follow-up for some patients.
The participation of the recruited women has contributed to more than 60 research papers since 2001 (see Publication list, Anne Cathrine Staff )and to a better understanding of pregnancy pathophysiology.
The women are either included during pregnancy, regardless of later mode of delivery, or directly before cesarean section. For the first group, only maternal blood is collected. For the latter group both maternal and fetal blood (artery and vein sampling from the umbilical cord) is collected together with decidual tissue, placenta, amniotic fluid and subcutaneous fat tissue samples from the mother during the cesarean section.
OPB-Postpartum studies (CHASE and HAPPY PATH)
Our aim is to follow patients after their index pregnancy and relate pregnancy findings to later maternal and fetal health. Our long term goal is to improve maternal and fetal health, and use pregnancy findings to identify individuals at excessive risk for cardiovascular disease, and to provide prophylactic measures that prevents postpones cardiovascular disease.
A small group of women and offspring (69 mother and child pairs) was recruited postpartum (2009-10), as follow-up 5-8 years after previous inclusion to the Oslo Pregnancy Biobank. Several interesting data emerged from this project, indicating that maternal and offspring endothelial health differed after pregnancy complications such as preeclampsia with a small for gestational age baby.
HAPPY-study (recruiting from 2014)
1 and 3 year clinical follow-up after delivery is offered women that delivered at OUH and where placenta (decidual) tissue is evaluated for “acute atherosis”. HAPPY focuses on maternal long-term cardiovascular health after pregnancy and is paralleled by a laboratory investigation of this atherotic vascular lesion at a molecular level,
The primary aim of PATH is to identify molecular mechanisms of uteroplacental acute
atherosis and explore its potential in identifying future cardiovascular disease
(CVD) in recently pregnant women.
Ethical and institutional approvals of the OPB studies
PI: Professor Annetine Staff (AS) is head of ResCOG and also principal investigator (PI), responsible for the
Pregnancy related biobanks, here in short named “Oslo Pregnancy Biobank”, (OPB).
Research ethics: All included patients provide informed written consent after thorough oral information. All studies are approved by the REC (Regional Committees for Medical and Health Research Ethics) in Norway (REC South East, following local approval at the Dept and at the hospital centrally
Oslo Pregnancy Biobank REK: From 2015 OPB 2010/1850/REKsør-øst C, (ref 529-02162).
CHASE REK: 190109, ref S-08810d/20941
HAPPY REK: 2013/2092/REK Sør-Øst
All research studies in OPB are regarded as highly justified and without harm for the participants, and have large potential for short- and long term positive health effects for the participants.
No patient in OPB undergoes cesarean section solely for the purpose of research. The indication for CS is made by a qualified medical doctor that is independent of the research personnel recruiting the patient. The patient is then recruited by either a medical doctor in the research group, or other research personnel that are involved in the study and under the supervision of the PI. Recruitment will not be performed in an emergency situation, but only when the patient has had sufficient time to consider participation.
Administrative approval hospital:
Head of the Department of Gynecology, senior consultant Marit Lieng (as of 2016), is the institutional legal representative, together with clinic chief executive officer (head) of the Division of Gynaecology and Obstetrics, consultant Bjørn Busund (as of 2016). Local approval is also obtained from Leader of the Department of Obstetrics Kristi Hjelle through local Obstetrical Department Leader Ullevål, Professor Anne Flem Jacobsen.
Oslo Pregnancy Biobank Reference Group:
As of 2010 there is a reference group for the Pregnancy biobank with Annetine Staff as PI. The purpose of the Reference Group is to provide support for the PI and to assist in securing that use of databases and biobank material is in agreement with current legislation and approvals.
The Reference Group consists of:
PI Annetine Staff, Oslo University Hospital (OUH)
Head of patient and IT security at OUH, Heidi Thorstensen.
Head of the Department of Obstetrics, OUH, Ullevål, Anne Flem Jacobsen.
Head of Research at the Division of Paediatric and Adolescent Medicine, OUH, Karin C Lødrup Carlsen.
Patient representative (as of 2016), can be contacted by Research Coordinator Michael Pilemand Hjørnholm (firstname.lastname@example.org).
Diagnosis Revision Team (DRT):
As from 2014, a team consisting of at least two experienced consultants in obstetrics (in the ResCOG team) will crosscheck the final diagnoses for the OPB entered into the SPSS dataset.