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

Completed

• Conditions: Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
• Interventions: Drug: Diflucortolone valerate (BAY866146)

• Registration Number: NCT03788863
• Lead Sponsor: LEO Pharma

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-16
• Primary Completion: 2018-11-29
• Study Completion: 2018-11-29
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-27
• Study First Posted: 2018-12-28
• Status Verified: 2019-11
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99999

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women exposed to glucocorticoids	Diflucortolone valerate (BAY866146)	Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy

Primary Outcome Measures

Name	Time	Method
Incidence of any type of orofacial cleft	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 Outcome Measures

Name	Time	Method
Potency (mild, moderate, potent, very potent) of glucocorticosteroids	Retrospective analysis from 1-Jan-1997 to 25-Jun-2018	Potency of glucocorticoid; * Mild; * Moderate; * Potent; * Very potent
Route of administration of glucocorticosteroids	Retrospective analysis from 1-Jan-1997 to 25-Jun-2018	Route of administration: * Topical; * Systemic; * Any other form of use
Types of orofacial cleft	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)

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany