Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft DevelopmentNCT03788863
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
An observational study of Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development, run by LEO Pharma at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development
- What is being tested?
- Diflucortolone valerate (BAY866146)
- How many people
- 99,999 participants
- Where
- 1 siteGermany
- Study dates
- 16 Nov 2018to 29 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
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.
- Being tested
- Diflucortolone valerate (BAY866146)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diflucortolone valerate (BAY866146)Drug
Follow clinical administration
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women exposed to glucocorticoids | Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy Receives: Drug: Diflucortolone valerate (BAY866146) | |
| Non-exposed pregnant women | Women not using any glucocorticoid or corticosteroid or steroids during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Secondary outcomes (3)
Potency (mild, moderate, potent, very potent) of glucocorticosteroids
Potency of glucocorticoid
- Mild
- Moderate
- Potent
- Very potent
Measured: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Route of administration of glucocorticosteroids
Route of administration:
- Topical
- Systemic
- Any other form of use
Measured: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Types of orofacial cleft
Types of orofacial cleft
- Cleft lip (CP)
- Cleft lip with or without palate (CLP)
- Cleft palate (CP)
- Orofacial cleft (OC)
Measured: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start16 Nov 2018
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788863
- Sponsor's protocol ID
- 20638
- Status last verified
- Nov 2019
- First submitted
- 13 Dec 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Association of Orofacial Cleft and Glucocorticoids Exposure During Pregnancy: a Meta-analysis
- ClinicalTrials.gov ID
- NCT03788863
- Acronym / sponsor ID
- 20638
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99,999 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women exposed to glucocorticoids | – | Drug: Diflucortolone valerate (BAY866146)Pregnant women exposed to any glucocorticoid or corticosteroid or steroids in early pregnancy or first trimester of pregnancy |
| Non-exposed pregnant women | – | –Women not using any glucocorticoid or corticosteroid or steroids during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- Population: Nonpregnant women
- Intervention: Drugs other than glucocorticoid or corticosteroid or steroid
- Outcomes: Incidence/ risk of cleft lip/palate in infants
- Study Design:
- Studies focusing on:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diflucortolone valerate (BAY866146)Follow clinical administration | Drug | Pregnant women exposed to glucocorticoids |
Primary outcome
Incidence of any type of orofacial cleft
Time frame: 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.
3 secondary outcomes
Potency (mild, moderate, potent, very potent) of glucocorticosteroids
Time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Route of administration of glucocorticosteroids
Time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Types of orofacial cleft
Time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relationship Between the Exposure of Glucocorticoids During Pregnancy and Orofacial Cleft Development, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any type of orofacial cleft (time frame: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.