Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
Screen-tox
2 other identifiers
observational
602
1 country
1
Brief Summary
The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm for individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension (PIH) is suitable to identify women in high risk of developing these diseases in a Norwegian population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 13, 2017
February 1, 2017
2.2 years
September 1, 2010
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Development of preeclampsia
september 2012
Onset time of preeclampsia
September 2012
Secondary Outcomes (5)
Gestational age at delivery
September 2012
Number of induction of deliveries due to preeclampsia
September 2010
Number of instrumental deliveries due to preeclampsia
September 2012
Perinatal morbidity
September 2012
Maternal morbidity
September 2012
Eligibility Criteria
Pregnant women
You may qualify if:
- Pregnant
- Nulliparous
- Para 1+ with previous preeclampsia or gestational hypertension
- Residence in Trondheim + 8 surrounding municipalities
You may not qualify if:
- Pregnancy length \> 13+6 weeks (CRL \> 85 mm)
- Twins
- Missed abortion
- Fetal anomaly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
National Center for Fetal Medicine, St Olavs Hospital
Trondheim, 7006 Trondheim, Norway
Related Publications (2)
Skrastad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KA. Risk assessment for preeclampsia in nulliparous women at 11-13 weeks gestational age: prospective evaluation of two algorithms. BJOG. 2015 Dec;122(13):1781-8. doi: 10.1111/1471-0528.13194. Epub 2014 Dec 4.
PMID: 25471057RESULTSkrastad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KA. A prospective study of screening for hypertensive disorders of pregnancy at 11-13 weeks in a Scandinavian population. Acta Obstet Gynecol Scand. 2014 Dec;93(12):1238-47. doi: 10.1111/aogs.12479. Epub 2014 Sep 17.
PMID: 25146367RESULT
Biospecimen
Blood samples Urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ragnhild B Skraastad, Cand Med
LBK, NTNU, National Center for Fetal Medicine
- STUDY DIRECTOR
Kjell Aa Salvesen, Dr Med
LBK, NTNU, National Center for Fetal Medicine
- STUDY DIRECTOR
Harm-Gerd K Blaas, Dr Med
LBK, NTNU, National Center for Fetal Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2010
First Posted
September 6, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2012
Study Completion
October 1, 2013
Last Updated
February 13, 2017
Record last verified: 2017-02