Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development Clinical Trial
Official title:
Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
| NCT number | NCT03788863 |
| Other study ID # | 20638 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 16, 2018 |
| Est. completion date | November 29, 2018 |
| Verified date | November 2019 |
| Source | LEO Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 99999 |
| Est. completion date | November 29, 2018 |
| Est. primary completion date | November 29, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Many locations | Multiple Locations |
| Lead Sponsor | Collaborator |
|---|---|
| LEO Pharma | Bayer |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 |