Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

Completed

• Conditions: Preeclampsia

• Registration Number: NCT01195441
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-01
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Primary Completion: 2012-11
• Study Completion: 2013-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 602

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of preeclampsia	september 2012
Onset time of preeclampsia	September 2012

Secondary Outcome Measures

Name	Time	Method
Number of instrumental deliveries due to preeclampsia	September 2012
Gestational age at delivery	September 2012
Number of induction of deliveries due to preeclampsia	September 2010
Maternal morbidity	September 2012
Perinatal morbidity	September 2012

Trial Locations

Locations (1)

National Center for Fetal Medicine, St Olavs Hospital; 🇳🇴 Trondheim, Norway