Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

NCT ID: NCT01195441

Last Updated: 2017-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnancy length \> 13+6 weeks (CRL \> 85 mm)
* Twins
* Missed abortion
* Fetal anomaly
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ragnhild B Skraastad, Cand Med

Role: PRINCIPAL_INVESTIGATOR

LBK, NTNU, National Center for Fetal Medicine

Kjell Aa Salvesen, Dr Med

Role: STUDY_DIRECTOR

LBK, NTNU, National Center for Fetal Medicine

Harm-Gerd K Blaas, Dr Med

Role: STUDY_DIRECTOR

LBK, NTNU, National Center for Fetal Medicine

Locations

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National Center for Fetal Medicine, St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 25471057 (View on PubMed)

Skrastad 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.

Reference Type RESULT
PMID: 25146367 (View on PubMed)

Other Identifiers

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2009-017833-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EUDRACTNUMMER 2009-017833-23

Identifier Type: -

Identifier Source: org_study_id

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