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

Norwegian University of Science and Technology

Status: Completed

Conditions: Preeclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT01195441

EUDRACTNUMMER 2009-017833-23

2009-017833-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 602 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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