A Study to Learn More About the Relationship Between the... | NCT03788863

Studies
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

NCT03788863

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Apr 1, 2020Actual

Enrollment

99,999Actual

Phase

Not provided

Conditions

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

Interventions

Diflucortolone valerate (BAY866146)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2018Actual

Primary Completion Date

Nov 29, 2018Actual

Completion Date

Nov 29, 2018Actual

First Submitted Date

Dec 13, 2018

First Submission Date that Met QC Criteria

Dec 27, 2018

First Posted Date

Dec 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2020

Last Update Posted Date

Apr 1, 2020Actual

Name	Class
Bayer	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

99,999Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women exposed to glucocorticoids		Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy	Drug: Diflucortolone valerate (BAY866146)
Non-exposed pregnant women		Women not using any glucocorticoid or corticosteroid or steroids during pregnancy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diflucortolone valerate (BAY866146)	Drug	Follow clinical administration	Pregnant women exposed to glucocorticoids

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample