Clinical trial 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
Official title: Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2018-12-28
Enrollment: 99999
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy irrespective of mode of administration identified through a systematic review of articles published up to 25 June 2018 by pre-specified inclusion and exclusion criteria. In total 18 observational studies have been selected for this meta-analysis with sample size for individual studies ranging from 106 to 832,636 patients.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of any type of orofacial cleft
timeFrame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Secondary outcomes:
measure: Potency (mild, moderate, potent, very potent) of glucocorticosteroids
timeFrame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
measure: Route of administration of glucocorticosteroids
timeFrame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
measure: Types of orofacial cleft
timeFrame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Many locations
Study officials:
References: