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临床试验/NCT00267735
NCT00267735已完成不适用

Measuring Preferences for Childbirth After Cesarean

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
131
试验地点
2
主要终点
Decisional conflict scores (knowledge of options; clarity about preferences; decisional certainty; conflict) after using decision aid.

研究概览

简要总结

The objective of this proposed 18-month exploratory research study is to help pregnant women weigh risks and benefits in a childbirth decision using the Preferences-Assessment Computer Module. Our hypothesis is that, after using this computer module, women will be more aware of the potential risks and benefits of VBAC and of elective repeat cesarean and will have greater clarity about their preferences related to these risks and benefits.

详细描述

As cesarean birth rates continue to climb, the number of women (currently about 420,000 annually) facing the decision of whether to have a repeat cesarean or to attempt a vaginal birth after cesarean (VBAC) will also increase. The objective of this proposed 18-month exploratory research study is to help pregnant women weigh risks and benefits in a childbirth decision using the Preferences Assessment Computer Module developed by the principal investigator. The long-term objective of the proposed research is to understand and improve the decision-making process of these women by creating a computerized childbirth decision aid. Such decision aids provide value when the decision is complex, when the outcome is uncertain, and when people vary in how they prioritize preferences; childbirth decisions for women with a prior cesarean meet all these criteria.

No study to date quantifies how women weigh the complexities of various considerations-medical and otherwise-in the delivery decision. The proposed research is significant, therefore, in that it will provide a much-needed method to help women prioritize and weigh their preferences related to childbirth decisions. More broadly, it responds to the recent NIH and AHRQ initiatives to promote the development of computerized decision aids to improve the quality of medical decisions.

A new investigator will lead a well-qualified, multi-disciplined team that has expertise in decision analysis, obstetric medicine, and research methodology in pursuit of the following specific aims:

  1. To validate a precise method to measure childbirth preferences. During the initial phase of this study, we will verify the accuracy of the Preferences Assessment Computer Module, measure internal consistency and assess content validity in a cross-sectional study.
  2. To test whether women who use the Preferences Assessment Computer Module will have increased clarity about their preferences-and about the implication of those preferences-in comparison to women in a control group. We will conduct a randomized controlled trial of pregnant women with a prior cesarean.

This Preferences Assessment Computer Module is appropriate to address not only VBAC decisions, but also decisions related to elective cesareans and induction. In short, the proposed research will advance the field by improving the quality of the decision-making process for childbirth.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18 or older
  • candidate for VBAC
  • singleton pregnancy
  • one prior cesarean
  • with a non-vertical uterine scar
  • English or Spanish speaking

排除标准

  • more than one prior cesarean

结局指标

主要结局

Decisional conflict scores (knowledge of options; clarity about preferences; decisional certainty; conflict) after using decision aid.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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