Clinical trial NCT01195441: Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
Official title: Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: Preeclampsia
Doppler ultrasound
First trimester
Acetylsalicylic acid
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2010-09-06
Enrollment: 602
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of preeclampsia
timeFrame: september 2012
measure: Onset time of preeclampsia
timeFrame: September 2012
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: September 2012
measure: Number of induction of deliveries due to preeclampsia
timeFrame: September 2010
measure: Number of instrumental deliveries due to preeclampsia
timeFrame: September 2012
measure: Perinatal morbidity
timeFrame: September 2012
measure: Maternal morbidity
timeFrame: September 2012
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: National Center for Fetal Medicine, St Olavs Hospital
Study officials:
affiliation: LBK, NTNU, National Center for Fetal Medicine
name: Ragnhild B Skraastad, Cand Med
role: PRINCIPAL_INVESTIGATOR
affiliation: LBK, NTNU, National Center for Fetal Medicine
name: Kjell Aa Salvesen, Dr Med
role: STUDY_DIRECTOR
affiliation: LBK, NTNU, National Center for Fetal Medicine
name: Harm-Gerd K Blaas, Dr Med
role: STUDY_DIRECTOR
References:
citation: Skrastad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KA. 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. Epub 2014 Dec 4.
citation: Skrastad RB, Hov GG, Blaas HG, Romundstad PR, Salvesen KA. 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. Epub 2014 Sep 17.