Risk calculation for Pre-Eclampsie and Grwoth Restriction in the First Trimester
Completed
- Conditions
- Pre-eclampsia - New-onset Hypertension and Proteinuria in Pregnancy1001027310057166
- Registration Number
- NL-OMON39085
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3000
Inclusion Criteria
Primigravida
Viable singleton pregnancy < 12 weeks of gestation
Informed consent given
Exclusion Criteria
Minors (being under the age of 18)
Incapacitated persons
Not mastering the Dutch language
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main objective of the study is to evaluate the performance of two existing<br /><br>algorithms for the prediction of PE and growth restriction not associated with<br /><br>PE. These algorithms (including the following variables: ethnicity, body mass<br /><br>index (BMI), mean arterial pressure (MAP), lowest Doppler resistance<br /><br>measurement (PI) of both uterine arteries and maternal serum blood markers<br /><br>(PAPP-A and PLGF)) will be tested and other possible combinations of variables<br /><br>will be evaluated for their predictive ability. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives:<br /><br>- Evaluating the learning curve for measurement of the uterine arteries<br /><br>- Inter and intra- observer variation of measurement of the uterine arteries<br /><br>- Quality assessment of the measurements of the uterine arteries<br /><br>- Time needed to collect informed consent, maternal history and measurement of<br /><br>the maternal blood pressure and uterine arteries </p><br>