Trial Condition(s):

Relationship between the exposure of glucocorticoids during pregnancy and orofacial cleft development

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

Bayer Identifier:

20638 Identifier:


EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Diflucortolone valerate (BAY866146)
Accepts Healthy Volunteers

Where to Participate


Many locations

Many locations, Germany


Trial Design