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

This study has been completed.
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: February 10, 2017
Last verified: February 2017
  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:


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

Primary Outcome Measures:
  • Development of preeclampsia [ Time Frame: september 2012 ]
  • Onset time of preeclampsia [ Time Frame: September 2012 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Blood samples Urine

Enrollment: 602
Actual Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: November 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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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 ( EudraCT Number )
Study First Received: September 1, 2010
Last Updated: February 10, 2017

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 May 24, 2017