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临床试验/NCT05838313
NCT05838313已完成不适用

Should I Have an Elective Induction? The SELECTION Study

University of South Florida2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Proportion of People Completely Viewing the Decision Support Tool

研究概览

简要总结

The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation

详细描述

60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Pregnant person
  • •Nulliparous
  • •Planned vaginal delivery
  • •No medical indication for induction of labor

排除标准

  • •Contraindication to vaginal delivery
  • •Prior delivery (vaginal or cesarean)
  • •Medical indication for induction of labor

研究组 & 干预措施

Decision Support Tool

Experimental

Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication

干预措施: Elective Induction of Labor Decision Support Tool (Behavioral)

结局指标

主要结局

Proportion of People Completely Viewing the Decision Support Tool

时间窗: 36-38 weeks gestation

The proportion of participants who view all of the pages of the decision support tool will be calculated

Recruitment Rate

时间窗: 32-38 weeks gestation

Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study

次要结局

  • Satisfaction With the Decision Support Tool(38-39 weeks gestation, prior to delivery)
  • Impact of App on Decision Making(2-4 weeks Postpartum)
  • Satisfaction With the Decision Support Tool(36-38 weeks gestation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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