Investigation of Prenatal Steroids for Treatment of Prenatally Diagnosed CCAMs
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Incidence of Hydrops Fetalis
研究概览
简要总结
Congenital cystic adenomatoid malformations (CCAMs) are theorized to be growing immature lung tissue. Administration of maternal steroids in the mid-trimester may stop the growth or decrease the size of the CCAM, thus increasing normal lung tissue and improving survival in fetuses with large CCAMs. This is a prospective, blinded, randomized trial comparing administration of a single course of antenatal steroids (Betamethasone) to control (i.e., placebo). The primary outcome variable will be incidence of hydrops. One month postnatal survival and relative size of the CCAM as determined by CCAM volume:head circumference ratio (CVR) between treatment/no treatment groups will be secondary outcome variables. Change in size of CCAM will be serially followed for both groups with individual growth curves being plotted prenatally and these will be compared with pathology weigh and volume to evaluate treatment effect. Other prenatal data collected will include: incidence of polyhydramnios, incidence of premature rupture of membranes, incidence of material complications. We will also compare mode of delivery, postnatal respiratory compromise, need for resection in the first week of life, and occurrence of complications during newborn administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •GA < 26 weeks
- •Maternal age > 18 years of age
- •Singleton pregnancy
- •Normal chromosomes
- •CCAM volume to head circumference ratio (CVR) > 1.4
- •No maternal medical/surgical contraindications
- •No evidence of hydrops
- •Not previously randomization
排除标准
- •Maternal diabetes or use of insulin
- •Preterm labor
- •Multiple congenital anomalies with CCAM
- •Chromosomal anomaly with CCAM
- •Multiple gestation pregnancy with CCAM
- •Not willing to be randomized
- •Unable or unwilling to return to UCSF for second dose of drug or placebo
- •CVR < 1.4
研究组 & 干预措施
Active Study Group
STEROID: Betamethasone; 12 mg intramuscularly x 2 doses 24 hours apart
干预措施: Betamethasone (Drug)
Placebo Group
PLACEBO: IM x 2 doses 24 hours apart
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Hydrops Fetalis
时间窗: Delivery, up to approximately 20 weeks post-enrollment
次要结局
- Comparison of CCAM Size in Mid-trimester Fetuses (Study/Administration vs Control/Placebo)(Baseline, Delivery (up to approximately 20 weeks post-enrollment))
- Survival at One-month Between Study and Control Groups.(30 days after delivery (up to approximately 24 weeks post-enrollment))
