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

LEO Pharma

Status: Completed

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

Treatments: Drug: Diflucortolone valerate (BAY866146)

Study type: Observational

Funder types: Industry

Identifiers

NCT03788863

20638

Details and patient eligibility

About

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.

Enrollment: 99,999 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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 design

99,999 participants in 2 patient groups

Pregnant women exposed to glucocorticoids

Description:

Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy

Treatment:

Drug: Diflucortolone valerate (BAY866146)

Non-exposed pregnant women

Description:

Women not using any glucocorticoid or corticosteroid or steroids during pregnancy