PreeclampsiaScreen-toxNCT01195441
Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- How many people
- 602 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Pregnant
- Nulliparous
- Para 1+ with previous preeclampsia or gestational hypertension
- last menstrual period (LMP) pregnancy length at inclusion < 13 weeks
- Residence in Trondheim + 8 surrounding municipalities
Who cannot join
- Pregnancy length > 13+6 weeks (CRL > 85 mm)
- Twins
- Missed abortion
- Fetal anomaly
Trial locations and contacts
1 site in 1 country.
Norway1 site
National Center for Fetal Medicine, St Olavs Hospital
Trondheim, 7006 Trondheim
About this study
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.
Read the detailed description
It has been shown that low dose acetylsalicylic acid (ASA) in pregnancy reduces adverse outcome of pregnancy in women that have high risk of developing preeclampsia (PE). It is a challenge for the clinician to identify the high risk women. Doppler blood flow measurements in uterine arteries in second trimester have been shown useful to predict the development of the disease but prophylactic treatment with ASA from this point in pregnancy has not been proven effective. Fetal Medical Foundation has developed an algorithm that calculates individual risks for PE/ PIH based on Doppler blood flow measurements and anamnestic information.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Doppler ultrasound, First trimester, Acetylsalicylic acid
- Medical subject headings
- Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of preeclampsia
Measured: september 2012
Onset time of preeclampsia
Measured: September 2012
Secondary outcomes (5)
Gestational age at delivery
Measured: September 2012
Number of induction of deliveries due to preeclampsia
Measured: September 2010
Number of instrumental deliveries due to preeclampsia
Measured: September 2012
Perinatal morbidity
Measured: September 2012
Maternal morbidity
Measured: September 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Ragnhild B Skraastad, Cand Med, Principal investigator, LBK, NTNU, National Center for Fetal MedicineKjell Aa Salvesen, Dr Med, Study director, LBK, NTNU, National Center for Fetal MedicineHarm-Gerd K Blaas, Dr Med, Study director, LBK, NTNU, National Center for Fetal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195441
- Sponsor's protocol ID
- EUDRACTNUMMER 2009-017833-23
- Other IDs
- 2009-017833-23, 2009
- Acronym
- Screen-tox
- Status last verified
- Feb 2017
- First submitted
- 1 Sep 2010
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25471057Skrastad 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.
PubMed 25146367
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
- ClinicalTrials.gov ID
- NCT01195441
- Acronym / sponsor ID
- Screen-tox / EUDRACTNUMMER 2009-017833-23
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Doppler ultrasound, First trimester, Acetylsalicylic acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2010 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It has been shown that low dose acetylsalicylic acid (ASA) in pregnancy reduces adverse outcome of pregnancy in women that have high risk of developing preeclampsia (PE). It is a challenge for the clinician to identify the high risk women. Doppler blood flow measurements in uterine arteries in second trimester have been shown useful to predict the development of the disease but prophylactic treatment with ASA from this point in pregnancy has not been proven effective. Fetal Medical Foundation has developed an algorithm that calculates individual risks for PE/ PIH based on Doppler blood flow measurements and anamnestic information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (5 listed)
- Pregnant
- Nulliparous
- Para 1+ with previous preeclampsia or gestational hypertension
- last menstrual period (LMP) pregnancy length at inclusion < 13 weeks
- Residence in Trondheim + 8 surrounding municipalities
Key exclusion criteria (4 listed)
- Pregnancy length > 13+6 weeks (CRL > 85 mm)
- Twins
- Missed abortion
- Fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of preeclampsia
Time frame: september 2012
Onset time of preeclampsia
Time frame: September 2012
5 secondary outcomes
Gestational age at delivery
Time frame: September 2012
Number of induction of deliveries due to preeclampsia
Time frame: September 2010
Number of instrumental deliveries due to preeclampsia
Time frame: September 2012
Perinatal morbidity
Time frame: September 2012
Maternal morbidity
Time frame: September 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Results publication: PubMed 25471057Skrastad 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.
- Results publication: PubMed 25146367Skrastad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnhild B Skraastad, Cand Med principal investigator
LBK, NTNU, National Center for Fetal Medicine
Kjell Aa Salvesen, Dr Med study director
LBK, NTNU, National Center for Fetal Medicine
Harm-Gerd K Blaas, Dr Med study director
LBK, NTNU, National Center for Fetal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of preeclampsia (time frame: september 2012). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01195441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.