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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03788863

Enrollment

99999

Registered

2018-12-28

Start date

2018-11-16

Completion date

2018-11-29

Last updated

2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGDiflucortolone valerate (BAY866146)

Follow clinical administration

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of any type of orofacial cleft	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

Measure	Time frame	Description
Potency (mild, moderate, potent, very potent) of glucocorticosteroids	Retrospective analysis from 1-Jan-1997 to 25-Jun-2018	Potency of glucocorticoid * Mild * Moderate * Potent * Very potent
Route of administration of glucocorticosteroids	Retrospective analysis from 1-Jan-1997 to 25-Jun-2018	Route of administration: * Topical * Systemic * Any other form of use
Types of orofacial cleft	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026