A Study to Learn More About the Relationship Between the Development of a Gap in the Upper Lip (C… (NCT03788863) | Clinical Trial Compass
CompletedNot Applicable
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
Germany99,999 participantsStarted 2018-11-16
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of any type of orofacial cleft
Timeframe: Retrospective analysis from 1-Jan-1997 to 25-Jun-2018