Early Education of Prematurity in High Risk Pregnancies-A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Parental satisfaction with prematurity education.
研究概览
简要总结
Prematurity is associated with significant morbidity and mortality. Given the high risk of death and disability, it is important for parents to understand the complications of prematurity so they can make decisions for their child. Unfortunately, these discussions often occur in the acute setting of threatened preterm labor when stress and anxiety make comprehension difficult. This study aims to improve parental understanding by providing early education of prematurity in the clinic setting for patients at high risk of preterm delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 22 0/7 and 34 6/7 weeks gestational age at high risk for premature delivery.
- •Premature delivery defined as <37 0/7 weeks gestation.
- •Any pregnant woman seen in the Maternal-Fetal Medicine Clinic deemed to be at high risk for premature delivery.
- •Pregnant women 16 years and older.
- •Pregnancy with singleton or twin gestation.
- •No major congenital malformation.
- •Women who are English speaking.
排除标准
- •Pregnant women <22 0/7 or >35 0/7 weeks gestational age.
- •Pregnant women less than 16 years old.
- •Multiple gestation greater than twins (triplets, quadruplets, etc).
- •Known major congenital malformation.
- •Women who are non-English speaking.
结局指标
主要结局
Parental satisfaction with prematurity education.
时间窗: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
Survey to assess usefulness of web-based educational tool and satisfaction with early education of prematurity.
Parental knowledge of prematurity.
时间窗: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
Questionnaire to assess parental knowledge regarding basic concepts of prematurity, associated complications and factors that improve survival.
Parental anxiety.
时间窗: Outcome will be assessed on day 1 of the study. Data will be analyzed and reported at the completion of the study.
Evaluation of parental anxiety associated with prematurity using validated six-item short-form of the Spielberger State-Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory (STAI) measures presence and severity of anxiety. The inventory consists of two self-reporting subscales that evaluate the current state of anxiety (state anxiety subscale), as well as the propensity towards being anxious (trait anxiety subscale). The range for total score is 20-80, with a higher score indicating greater anxiety. The six-item version of the Spielberger State-Trait Anxiety Inventory (STAI: Y-6 item) is composed of three-questions from the original state anxiety subscale and three-questions from the original trait anxiety subscale. This shortened six-item inventory is a reliable and valid instrument when compared to the full forty-question inventory.
次要结局
- Maternal compliance with maternal-fetal medicine provider follow up.(Outcome will be assessed up to 9 months following completion of the counseling intervention. Data will be analyzed and reported at the completion of the study.)
研究者
Rebecca Fish
Principal Investigator
University Hospitals Cleveland Medical Center