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

Overview

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.

Full Title of Study: “Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Retrospective
• Study Primary Completion Date: November 29, 2018

Interventions

• Drug: Diflucortolone valerate (BAY866146)
  • Follow clinical administration

Arms, Groups and Cohorts

• Pregnant women exposed to glucocorticoids
  • Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy
• Non-exposed pregnant women
  • Women not using any glucocorticoid or corticosteroid or steroids during pregnancy

Clinical Trial Outcome Measures

Primary Measures

• Incidence of any type of orofacial cleft
  • Time Frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
  • Meta-analysis will be conducted with 18 observational studies. Oral clefts are defined as diagnosis of cleft lip with or without cleft palate or isolated cleft palate.

Secondary Measures

• Potency (mild, moderate, potent, very potent) of glucocorticosteroids
  • Time Frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
  • Potency of glucocorticoid Mild Moderate Potent Very potent
• Route of administration of glucocorticosteroids
  • Time Frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
  • Route of administration: Topical Systemic Any other form of use
• Types of orofacial cleft
  • Time Frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
  • Types of orofacial cleft Cleft lip (CP) Cleft lip with or without palate (CLP) Cleft palate (CP) Orofacial cleft (OC)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • LEO Pharma
• Collaborator
  • Bayer
• Provider of Information About this Clinical Study
  • Sponsor