Trial Condition(s):
Relationship between the exposure of glucocorticoids during pregnancy and orofacial cleft development
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
Bayer Identifier:
20638
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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:
2
Primary Outcome
- Incidence of any type of orofacial cleftMeta-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.Timeframe: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Secondary Outcome
- Potency (mild, moderate, potent, very potent) of glucocorticosteroidsPotency of glucocorticoid - Mild - Moderate - Potent - Very potentTimeframe: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
- Route of administration of glucocorticosteroidsRoute of administration: - Topical - Systemic - Any other form of useTimeframe: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
- Types of orofacial cleftTypes of orofacial cleft - Cleft lip (CP) - Cleft lip with or without palate (CLP) - Cleft palate (CP) - Orofacial cleft (OC)Timeframe: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Additional Information
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