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临床试验/NCT05506631
NCT05506631已完成不适用

Cost of Inpatient Care for Women Undergoing Outpatient vs. Inpatient Transcervical Balloon Cervical Ripening for Induction of Labor at Term

Lehigh Valley Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.

研究概览

简要总结

The objective of this study is to determine the impact of outpatient cervical ripening with transcervical balloon placement for induction of labor at term on the length and cost of inpatient hospitalization when compared to inpatient cervical ripening.

详细描述

The objective of the study is to determine the impact of outpatient cervical ripening with transcervical balloon placement for induction of labor at term on the length and cost of inpatient hospitalization when compared to inpatient cervical ripening.

Specific Aims

In conducting this study, the investigators will accomplish the following specific aim:

To compare the length of inpatient care for women undergoing cervical ripening with a transcervical Foley placed in the outpatient vs. inpatient setting prior to induction of labor.

  • Primary outcomes of interest
  • The length of time (measured in minutes) spent on the inpatient unit (L&D) from admission for cervical ripening and/or labor induction until delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups.

时间窗: 12 months

Cost Analysis in dollars Cost/charges will be calculated for the time spent in the outpatient and inpatient unit for both randomization groups. Cost will be based on information obtained from Enterprise Analytics charges for the time each woman spends in outpatient care, inpatient care, hospitalized from admission to the L\&D unit to delivery.

The length of time (measured in minutes) spent on the inpatient unit from admission from cervical ripening and/or labor induction until delivery.

时间窗: 12 months

The length of time (measured in minutes) spent on the inpatient unit (L\&D) from admission for cervical ripening and/or labor induction until delivery.

次要结局

  • Maternal length of stay(12 months)
  • Delivery(12 months)
  • Neonatal adverse events(12 months)
  • Maternal state(12 months)
  • Neonatal State(12 months)
  • ICU Length of stay(12 months)
  • Total Length of stay(12 months)
  • Cord PH(12 months)
  • Narcotic dosing(12 months)
  • Oxytocin dosing(12 months)
  • Maternal Adverse events(12 months)
  • Birthweight(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Quinones, MD

Vice Chair Research, Dept OBGYN, Lehigh Valley Health Network

Lehigh Valley Hospital

研究点 (2)

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