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Prediction and Prevention of Preeclampsia by First Trimester Ultrasound (Screen-tox)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01195441
First received: September 1, 2010
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Development of preeclampsia [ Time Frame: september 2012 ] [ Designated as safety issue: No ]
  • Onset time of preeclampsia [ Time Frame: September 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at delivery [ Time Frame: September 2012 ] [ Designated as safety issue: No ]
  • Number of induction of deliveries due to preeclampsia [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
  • Number of instrumental deliveries due to preeclampsia [ Time Frame: September 2012 ] [ Designated as safety issue: No ]
  • Perinatal morbidity [ Time Frame: September 2012 ] [ Designated as safety issue: No ]
  • Maternal morbidity [ Time Frame: September 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples Urine


Estimated Enrollment: 1500
Study Start Date: September 2010
Estimated Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195441

Locations
Norway
National Center for Fetal Medicine, St Olavs Hospital
Trondheim, Norway, 7006 Trondheim
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01195441     History of Changes
Other Study ID Numbers: EUDRACTNUMMER 2009-017833-23, 2009-017833-23
Study First Received: September 1, 2010
Last Updated: October 26, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Norwegian University of Science and Technology:
Preeclampsia
Doppler ultrasound
First trimester
Acetylsalicylic acid

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on June 17, 2013