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

Study Overview
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Brief Summary
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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.

Official Title
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Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis

Conditions
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Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development

Intervention / Treatment
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* Drug: Diflucortolone valerate (BAY866146)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women exposed to glucocorticoids<br>Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy | Drug: Diflucortolone valerate (BAY866146)<br>* Follow clinical administration<br>|
| Non-exposed pregnant women<br>Women not using any glucocorticoid or corticosteroid or steroids during pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Retrospective analysis from 1-Jan-1997 to 25-Jun-2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potency (mild, moderate, potent, very potent) of glucocorticosteroids | Potency of glucocorticoid Mild Moderate Potent Very potent | 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 | 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) | Retrospective analysis from 1-Jan-1997 to 25-Jun-2018 |