Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200571
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-12-08
Brief Title:
Biological Changes Associated With High Risk of Preeclampsia in Nulliparous Women
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Characterization of the Immunological and Vascular Effects of Aspirin in Prevention of Preeclampsia in High-risk Nulliparous Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRERISK
Brief Summary:
Primary outcome
1 to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation FMF
2 to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia
Secondary outcomes include findings of longitudinal development and predictive potential of biological markers associated with high-risk for preeclampsia and aspirin treatment
The main questions it aims to answer are
Is high risk for preeclampsia associated with biological changes during pregnancy
How does aspirin modulate the biological changes associated with high risk for preeclampsia
Nulliparous women will undergo routine clinical care at two regional hospitals with different treatment strategies and selected to the study in three groups low risk of preeclampsia high risk of preeclampsia without aspirin and high-risk of preeclampsia with aspirin treatment
1 to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation FMF
2 to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia
Secondary outcomes include findings of longitudinal development and predictive potential of biological markers associated with high-risk for preeclampsia and aspirin treatment
The main questions it aims to answer are
Is high risk for preeclampsia associated with biological changes during pregnancy
How does aspirin modulate the biological changes associated with high risk for preeclampsia
Nulliparous women will undergo routine clinical care at two regional hospitals with different treatment strategies and selected to the study in three groups low risk of preeclampsia high risk of preeclampsia without aspirin and high-risk of preeclampsia with aspirin treatment
Detailed Description:
St Olavs Hospital offers FMF-screening in week 11-14 and aspirin treatment through the Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial NCT06108947 FMF-screening and aspirin treatment are not part of routine clinical care at Alesund Hospital according to current recommendations from the Norwegian health authorities Alesund Hospital will therefore perform FMF-screening only to determine the project specific study groups Researchers will compare the three groups to identify biological changes associated with high risk for preeclampsia and the effect of aspirin
FMF- screening will be performed in week 11-14 after written informed consent approved by the the Regional Committee for Medical and Health Research Ethics in Central Norway REK-midt REK 537602 Screening includes patient history blood pressure uterine artery mean pulsatile index and serum placenta growth factor PlGF Standardized blood pressure will be measured by trained personnel Ultrasound scans will be performed by FMF certified doctors and midwives working at Alesund Hospital and the Center for Fetal Medicine at StOlavs Hospital in Trondheim PlGF in maternal serum will be analyzed with Roche or Kryptor technology
The investigators will include around 200 women 18 years or older with a singleton live fetus in three groups
Nulliparous women with low risk for preeclampsia at both hospitals
Nulliparous women with high risk for preeclampsia without aspirin at Alesund Hospital
Nulliparous women with high risk for preeclampsia with aspirin at St Olavs Hospital
Follow-up all three groups will have visits in week 22-24 32 and 38 and standard antenatal care after 37 weeks until delivery Fetal growth and Doppler will be assessed at the scheduled visits and according to clinical judgement by obstetricians at the outpatient clinic of the hospital Women will have follow-up 6 months after birth
Blood and urine will be sampled at five time points for all three groups week 11-14 22-24 32 38 and 6 months after birth for biological analyses Placenta samples and umbilical venous blood will be sampled at delivery
Biological materials will be investigated to answer the research questions described Biological changes in serum will be measured as cytokines by multiplex metabolites by NMR-analysis and lipids by NMR-analysis Vascular changes in the placenta will be measured by histopathological evaluation
The study will be registered in Clinicaltrialsgov
Funding and sponsors The study is funded by Helse-Midt Norge RHF The funding source has played no role in design of the study and will have no role in data collection analyses interpretation or publication
Participants Ann-Charlotte Iversen professor Phd Project leader Åse Turid Rossevatn Svoren consultant MD Phd candidate Kjell Åsmund Salvesen professor MD PhD Solveig Bjellmo consultant MD Phd
FMF- screening will be performed in week 11-14 after written informed consent approved by the the Regional Committee for Medical and Health Research Ethics in Central Norway REK-midt REK 537602 Screening includes patient history blood pressure uterine artery mean pulsatile index and serum placenta growth factor PlGF Standardized blood pressure will be measured by trained personnel Ultrasound scans will be performed by FMF certified doctors and midwives working at Alesund Hospital and the Center for Fetal Medicine at StOlavs Hospital in Trondheim PlGF in maternal serum will be analyzed with Roche or Kryptor technology
The investigators will include around 200 women 18 years or older with a singleton live fetus in three groups
Nulliparous women with low risk for preeclampsia at both hospitals
Nulliparous women with high risk for preeclampsia without aspirin at Alesund Hospital
Nulliparous women with high risk for preeclampsia with aspirin at St Olavs Hospital
Follow-up all three groups will have visits in week 22-24 32 and 38 and standard antenatal care after 37 weeks until delivery Fetal growth and Doppler will be assessed at the scheduled visits and according to clinical judgement by obstetricians at the outpatient clinic of the hospital Women will have follow-up 6 months after birth
Blood and urine will be sampled at five time points for all three groups week 11-14 22-24 32 38 and 6 months after birth for biological analyses Placenta samples and umbilical venous blood will be sampled at delivery
Biological materials will be investigated to answer the research questions described Biological changes in serum will be measured as cytokines by multiplex metabolites by NMR-analysis and lipids by NMR-analysis Vascular changes in the placenta will be measured by histopathological evaluation
The study will be registered in Clinicaltrialsgov
Funding and sponsors The study is funded by Helse-Midt Norge RHF The funding source has played no role in design of the study and will have no role in data collection analyses interpretation or publication
Participants Ann-Charlotte Iversen professor Phd Project leader Åse Turid Rossevatn Svoren consultant MD Phd candidate Kjell Åsmund Salvesen professor MD PhD Solveig Bjellmo consultant MD Phd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None