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临床试验/NCT02327637
NCT02327637终止不适用

A Comparison of Bed Rest Versus Moderate Activity Among Inpatient Antepartum Patients With Preterm Premature Rupture of Membranes (PPROM): A Randomized Controlled Trial

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
Change in Maternal Depression Score

研究概览

简要总结

Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).

详细描述

Historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. The definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). Recent studies have highlighted potential harmful effects from bed rest. However, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies.

PPROM is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the Unites States. Women with PPROM are routinely managed in the inpatient setting from the time of diagnosis until delivery. Therefore, PPROM patients are a closely supervised and easily accessible cohort of women.

In this study, participating patients with PPROM will be randomized into two groups: bedrest or moderate activity. Maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.

研究设计

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

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

  • Gestational age between 23 weeks 0 days - 32 weeks 0 days
  • Diagnosed with preterm premature rupture of membranes

排除标准

  • Cervical dilation greater than or equal to 3cm
  • Active labor
  • Evidence of infection
  • Inability to provide informed consent
  • Requirement for continuous fetal monitoring

结局指标

主要结局

Change in Maternal Depression Score

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.

次要结局

  • Change in Maternal Muscle Strength(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)
  • Change in Maternal Anxiety Score(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)

研究者

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

Louise Laurent, MD/PhD

Assistant Professor

University of California, San Diego

研究点 (2)

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