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

Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99,999 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development

Interventions

Type	Name	Description
DRUG	Diflucortolone valerate (BAY866146)	Follow clinical administration

Timeline

• Start date: 2018-11-16
• Primary completion: 2018-11-29
• Completion: 2018-11-29
• First posted: 2018-12-28
• Last updated: 2020-04-01

Locations

1 site across 1 country: Germany