Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
研究概览
详细说明
Progress in the frontiers of neonatology has continually pushed back the limit of viability and significantly improved the survival of extremely preterm infants. An important component of medical management before a preterm delivery is counseling the parents about probabilities of survival and long term complications.
Hypothesis: Preterm counseling is more effective when parents receive verbal counseling supplemented with written and pictorial information then verbal counseling alone.
Methodology: There will be two groups of study (verbal, pictorial and written vs verbal alone). All patients admitted to the L and D department of Stroger hospital between 23 to 34 weeks of gestation with threatened premature delivery will be enrolled in the study. They will be randomly assigned to 1 of 2 groups. After counseling, parents will be asked to complete a 32 point questionnaire to check their knowledge of outcomes of prematurity.
To reach statistically significant results, the investigators will need 40 patients in each group. The study will be done over a period of one year
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60612
- John H Stroger Jr Hospital of Cook County
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pregnant women between 23 to 34 weeks gestation assessed by obstetrician to need counseling
Exclusion Criteria:
- Pregnancies with known life threatening defects considered as non compatible with life.
- Mothers previously admitted and counseled will also be excluded
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Verbal counseling
Parents with threatened delivery will receive verbal counseling only
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Verbal counseling done by physician
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其他:Verbal, pictorial, written counseling
Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information
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verbal counseling in addition to gestational age specific written information and pictures will be given to parents
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient knowledge
大体时间:one year
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After counseling, patient will answer a 32 point questionnaire and this will be compared across the two groups to see there is any statistical difference between the two groups using SPSS
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Maternal anxiety level
大体时间:one year
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Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance
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one year
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合作者和调查者
调查人员
- 首席研究员:Mopelola Akintorin, MD、John H. Stroger Hospital
出版物和有用的链接
一般刊物
- Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
- Khashu M, Narayanan M, Bhargava S, Osiovich H. Perinatal outcomes associated with preterm birth at 33 to 36 weeks' gestation: a population-based cohort study. Pediatrics. 2009 Jan;123(1):109-13. doi: 10.1542/peds.2007-3743.
- Govande VP, Brasel KJ, Das UG, Koop JI, Lagatta J, Basir MA. Prenatal counseling beyond the threshold of viability. J Perinatol. 2013 May;33(5):358-62. doi: 10.1038/jp.2012.129. Epub 2012 Oct 18.
- Blanco F, Suresh G, Howard D, Soll RF. Ensuring accurate knowledge of prematurity outcomes for prenatal counseling. Pediatrics. 2005 Apr;115(4):e478-87. doi: 10.1542/peds.2004-1417.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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