Study 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

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

Trial summary

Enrollment Goal

99999

Trial Dates

November 2018 - November 2018

Phase

N/A

Could I Receive a placebo

Products

Diflucortolone valerate (BAY866146)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Many locations	Many 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.
Time 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
Time 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
Time 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)
Time 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

Click here to find results for studies related to Bayer products