Last reviewed · How we verify
NCT03375359: ReFaPo02
Reducing False Positives in Prenatal Screening
trial testing cfDNA screening in Pregnancy in 1,127 participants. Completed in 31 December 2019.
31 December 2019
Quick facts
| Lead sponsor | University Hospital Tuebingen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,127 |
| Start date | 8 January 2018 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- cfDNA screening
Conditions studied
- Pregnancy — all drugs for Pregnancy →
Sponsor
University Hospital Tuebingen
Who can join
18 and older, female only, with Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood. In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Genetics and Epigenetics of 22q11.2 Deletion Syndrome.
Du Q, de la Morena MT, van Oers NSC. · · 2019 · cited 77× · PMID 32117416 · DOI 10.3389/fgene.2019.01365
Verify or expand the search:
- PubMed search for NCT03375359
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital Tuebingen trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03375359 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital Tuebingen
- Last refreshed: 26 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03375359.
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