Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

Preeclampsia Clinical Trial

— Screen-tox  

Official title:

Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195441
• Other study ID #: EUDRACTNUMMER 2009-017833-23
• Secondary ID: 2009-017833-23
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: February 10, 2017
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: February 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: October 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Norway	National Center for Fetal Medicine, St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Skråstad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KÅ. 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. — View Citation

Skråstad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KÅ. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of preeclampsia		september 2012
Primary	Onset time of preeclampsia		September 2012
Secondary	Gestational age at delivery		September 2012
Secondary	Number of induction of deliveries due to preeclampsia		September 2010
Secondary	Number of instrumental deliveries due to preeclampsia		September 2012
Secondary	Perinatal morbidity		September 2012
Secondary	Maternal morbidity		September 2012