2024-511702-23-00招募中2 期
Clinical Trial on PREnatal Dexamethasone In Congenital adrenal hyperplasia Therapy - PREDICT -
Philipps-Universitaet Marburg2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2024年11月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Closure of urogenital sinus (Prader stage)
研究概览
简要总结
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)
入排标准
- 年龄范围
- In utero 至 64 years（0-17 Years, 18-64 Years, In utero）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Closure of urogenital sinus (Prader stage)
Closure of urogenital sinus (Prader stage)
Gestational weight gain (GWG) of mother
Gestational weight gain (GWG) of mother
次要结局
- Parameters of treatment consequences/safety in treated mothers and children
- safety parameters: stillbirths, miscarriages, maternal side effects and adverse events, serious adverse events (AEs, SAEs) in treated mothers and children, maternal quality of life, maternal mental health and sleep, child´s birth weight and height at birth, week of gestation at birth, infant nervous system development, malformations in the child)
研究者
KKS Marburg
Scientific
Philipps-Universitaet Marburg
研究点 (2)
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