Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01195441

Acronym

Screen-tox

Enrollment

602

Registered

2010-09-06

Start date

2010-09-30

Completion date

2013-10-31

Last updated

2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Preeclampsia, Doppler ultrasound, First trimester, Acetylsalicylic acid

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Development of preeclampsia	september 2012
Onset time of preeclampsia	September 2012

Secondary

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

Countries

Norway

Outcome results