Status:
COMPLETED
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
Lead Sponsor:
LEO Pharma
Collaborating Sponsors:
Bayer
Conditions:
Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
Eligibility:
FEMALE
Brief 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 syst...
Eligibility Criteria
Inclusion
- Population: Pregnant women
- Intervention: Any glucocorticoid or corticosteroid or steroids use irrespective of mode of administration
- Comparator: Any/none
- Outcomes: Incidence/ risk of cleft lip/palate in infants
- Study Design:
- Meta-analysis and systematic literature reviews
- Observational studies (such as cohort study, case-control study, registries data)
- Clinical trials - Phase IIb, III, and IV
- Conference abstracts/posters
- Time period: No time period restriction
- Geography: No geography restriction
Exclusion
- Population: Nonpregnant women
- Intervention: Drugs other than glucocorticoid or corticosteroid or steroid
- Outcomes: Incidence/ risk of cleft lip/palate in infants
- Study Design:
- Animal Study
- In vitro studies
- Editorial, letters, comment
- Clinical trials - Phase I or preclinical
- Case reports, case series
- Reviews
- Studies focusing on:
- Diagnosis and surgical procedure for cleft repair
- Impact of Increased internal corticosteroids due to stress
- The relationship between genetic mutations and cleft patients
- Adverse events for other drugs
- Safety profiles of glucocorticoid or corticosteroid
Key Trial Info
Start Date :
November 16 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2018
Estimated Enrollment :
99999 Patients enrolled
Trial Details
Trial ID
NCT03788863
Start Date
November 16 2018
End Date
November 29 2018
Last Update
April 1 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Many locations
Multiple Locations, Germany