on-invasive prenatal analysis of pregnancy-course and -outcome by genome-wide RNA sequencing
Completed
- Conditions
- Presymptomatic RNA profiling in pregnancy10026908
- Registration Number
- NL-OMON41926
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
Age 18 years or older at enrollment,
Clinically confirmed pregnancy,
Gestational age between 9-14 weeks,
Pregnancy records accessible and available for data collection exam,
Able to provide consent for participation using language appropriate forms.
Exclusion Criteria
Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment,
Twin pregnancy,
Vanishing twin.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the predictive accuracy of the nanoCAGE<br /><br>RNA-seq test for fetal and maternal well-being. Fetal well-being is monitored<br /><br>by intra-uterine growth restriction and preterm birth; maternal well-being is<br /><br>monitored by clinical symptoms of pre-eclampsia (new-onset hypertension during<br /><br>pregnancy with proteinuria) and related syndromes (HELLP syndrome).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is the discriminative power of the nanoCAGE RNA-seq test<br /><br>(proof-of-principle study) for the success of implantation rate and<br /><br>pathophysiological insight in early miscarriage using RNA isolated from the<br /><br>culture medium of human pre-implantation embryos (blastocyst stage).</p><br>