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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

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ClinicalTrials.gov Identifier: NCT03788863
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development Drug: Diflucortolone valerate (BAY866146)

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Study Type : Observational
Actual Enrollment : 99999 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : November 29, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788863


Locations
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Germany
Many locations
Multiple Locations, Germany
Sponsors and Collaborators
Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03788863     History of Changes
Other Study ID Numbers: 20638
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diflucortolone
Diflucortolone valerate
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents