Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Systematic review and meta-analysis
Study drug and medical condition

Name of medicine, other

Nerisona

Study drug International non-proprietary name (INN) or common name

DIFLUCORTOLONE VALERATE
Population studied

Short description of the study population

Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy irrespective of mode of administration.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Pregnant women

Estimated number of subjects

99999
Study design details

Main study objective

To conduct a meta-analysis of published literature to investigate the association between the exposure of glucocorticoids during pregnancy and orofacial cleft development

Outcomes

Incidence of any type of orofacial cleft, Potency of glucocorticosteroids, Route of administration of glucocorticosteroids

Data analysis plan

In total 18 observational studies have been selected for this meta-analysis with sample size for individual studies ranging from 106 to 832,636 patients. Based on the evidence identified, risk association of orofacial cleft and glucocorticoids exposure during pregnancy will be assessed by the odds ratios (ORs) with corresponding 95% credibility intervals (CIs). Direct treatment comparison with any glicocorticoid vs. no use will be conducted. Fixed effect model will be used. Various sub-groups and sensitivity analyses will be performed.