check_circleStudy Completed

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

Bayer Identifier:

20638

ClinicalTrials.gov Identifier:

NCT03788863

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Female

Age

NaN - N/A
  • - 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


  • - 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
99999
Trial Dates
November 2018 - November 2018
Phase
N/A
Could I Receive a placebo
No
Products
Diflucortolone valerate (BAY866146)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Retrospective analysis from 1-Jan-1997 to 25-Jun-2018

Secondary Outcome

  • Potency (mild, moderate, potent, very potent) of glucocorticosteroids
    Potency of glucocorticoid - Mild - Moderate - Potent - Very potent
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    Retrospective analysis from 1-Jan-1997 to 25-Jun-2018

Trial design

Risk association of orofacial cleft and glucocorticoids exposure during pregnancy: a meta-analysis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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