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NCT03788863
A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (Cleft Lip) or in the Roof of the Mouth (Cleft Palate) in Newborns and the Use of Glucocorticoids by the Mother During Pregnancy: a Meta-analysis
trial testing Diflucortolone valerate (BAY866146) in Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development in 99,999 participants. Completed in 29 November 2018.
29 November 2018
Quick facts
| Lead sponsor | LEO Pharma |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 99,999 |
| Start date | 16 November 2018 |
| Primary completion | 29 November 2018 |
| Estimated completion | 29 November 2018 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Diflucortolone valerate (BAY866146) — full drug profile →
Conditions studied
- Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development — all drugs for Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development →
Sponsor
LEO Pharma — full company profile →
Who can join
Eligibility, female only, with Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Glucocorticoids are drugs that have many effects on body metabolism, raise sugar level in the blood, and reduce inflammation. By applying a statistical technique for combining the findings from a systematic literature review (meta analysis), researchers want to learn more about the relationship of the risk to develop a separation in the roof of the mouth (cleft palate) in newborns and contact with glucocorticoids during pregnancy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03788863
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03788863 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
- Last refreshed: 1 April 2020
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/NCT03788863.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing