Many locations
Multiple Locations, Germany
Completed
NCT Number: NCT03788863
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
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.
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Notify MeKey information
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Diflucortolone valerate (BAY866146)
DrugFollow clinical administration
Primary outcomes
-
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 outcomes
-
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
-
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
-
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)
Sponsors and collaborators
Lead sponsor
LEO Pharma
Industry
Collaborators
- Bayer
Registry information
Official study title
Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
Important dates
- Study start
- 2018
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Dec 28, 2018
- Registry last updated
- Apr 1, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.