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

Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis

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.

Study Overview

• Status: Completed
• Conditions: Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
• Intervention / Treatment: Drug: Diflucortolone valerate (BAY866146)

• Study Type: Observational
• Enrollment (Actual): 99999

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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 identified through a systematic review of articles published up to 25 June 2018 by pre-specified inclusion and exclusion criteria. 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women exposed to glucocorticoids; Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy	Drug: Diflucortolone valerate (BAY866146); Follow clinical administration
Non-exposed pregnant women; Women not using any glucocorticoid or corticosteroid or steroids during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of any type of orofacial cleft	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.	Retrospective analysis from 1-Jan-1997 to 25-Jun-2018

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Diflucortolone valerate; Diflucortolone
• Other Study ID Numbers: 20638

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No