Non-invasive prenatal analysis of pregnancy-course and -outcome by genome-wide RNA sequencing

Non-invasive prenatal analysis of pregnancy-course and -outcome by genome-wide RNA sequencing - Presymptomatic RNA Profiling in Pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41926

Enrollment

2000

Registered

2015-01-21

Start date

2015-06-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Presymptomatic RNA profiling in pregnancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Invasive prenatal procedure (amniocentesis or CVS) performed within 2 weeks prior to enrollment, Twin pregnancy, Vanishing twin.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is the predictive accuracy of the nanoCAGE RNA-seq test for fetal and maternal well-being. Fetal well-being is monitored by intra-uterine growth restriction and preterm birth; maternal well-being is monitored by clinical symptoms of pre-eclampsia (new-onset hypertension during pregnancy with proteinuria) and related syndromes (HELLP syndrome).	—

Secondary

Measure	Time frame
The secondary endpoint is the discriminative power of the nanoCAGE RNA-seq test (proof-of-principle study) for the success of implantation rate and pathophysiological insight in early miscarriage using RNA isolated from the culture medium of human pre-implantation embryos (blastocyst stage).	—

Countries

Netherlands

Outcome results