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Clinical Trial on PREnatal Dexamethasone In Congenital adrenal hyperplasia Therapy - PREDICT -
EU CTIS ID: 2024-511702-23-00
What this study is testing
To investigate if a reduced dexamethasone dose is effective and non-inferior to the currently experimentally used high (“standard”) dose regimen in preventing prenatal virilization in females with classic congenital adrenal hyperplasia (CAH) and to investigate the effect on maternal weight gain during gestation (GWG)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult pregnant females with risk of classic CAH in their fetuses (genetic mutations in both parents)
- Written informed consent of the pregnant mother and the legal guardians of the unborn child
- GW <8+0 post menstruationem
You likely can't join if
- Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids
- Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (ALT or AST >2 times ULN])
- Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than therapy of CAH in the fetus or in the CAH affected mother herself
- History of malignancy (other than basal cell carcinoma successfully treated)
- Participation in a clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
- Body weight <50 kg or >95 kg before pregnancy
See the full eligibility criteria
- Adult pregnant females with risk of classic CAH in their fetuses (genetic mutations in both parents)
- Written informed consent of the pregnant mother and the legal guardians of the unborn child
- GW <8+0 post menstruationem
- Co-morbid condition requiring daily administration of a medication (or use of any medications/supplements) that interferes with the metabolism of glucocorticoids
- Clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (ALT or AST >2 times ULN])
- Subjects on regular daily inhaled, topical, nasal or oral steroids for any indication other than therapy of CAH in the fetus or in the CAH affected mother herself
- History of malignancy (other than basal cell carcinoma successfully treated)
- Participation in a clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
- Body weight <50 kg or >95 kg before pregnancy
- Subjects unable to comply with the requirements of the protocol
- Pregnancy with twins or multiples
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, in utero, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.