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Completed

NCT Number: NCT01195441

Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

National Center for Fetal Medicine, St Olavs Hospital

Trondheim, 7006 Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Development of preeclampsia

    Time frame: september 2012

  2. Onset time of preeclampsia

    Time frame: September 2012

Secondary outcomes

  1. Gestational age at delivery

    Time frame: September 2012

  2. Number of induction of deliveries due to preeclampsia

    Time frame: September 2010

  3. Number of instrumental deliveries due to preeclampsia

    Time frame: September 2012

  4. Perinatal morbidity

    Time frame: September 2012

  5. Maternal morbidity

    Time frame: September 2012

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Acronym: Screen-tox

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 6, 2010
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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