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临床试验/NCT04663607
NCT04663607已完成不适用

Randomized Controlled Trial Using Mobile Strategy to Reduce the Risk of Recurrent Preterm Birth

Stanford University4 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2021年10月7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
221
试验地点
4
主要终点
Interpregnancy interval

研究概览

简要总结

Preterm births are defined as delivery prior to 37 weeks gestation and account for 35% of infant deaths in the first year of life. Early preterm birth are deliveries prior to 32 weeks gestation and account for more than 70% of neonatal deaths and 36.1% of overall infant mortality. Women who have delivered a preterm infant and who have a short pregnancy interval (time between giving birth and subsequent conception) have an increased risk of preterm birth in subsequent pregnancies. The investigators hope to understand if a mobile health strategy can be used to reduce spontaneous preterm births via improved patient engagement, care coordination, and adherence to recommended care vs a traditional paper-based health strategy.

详细描述

The investigators hope to learn how to engage pregnant women at risk for preterm births and reduce the incidence of preterm births through this study. The goal of this study is to reduce the risk of recurrent preterm births for the participating mothers and healthy development of their infants. The investigators hope that this study will accomplish the following for the mothers: Utilize technology to strengthen knowledge of healthy behaviors; Improve adherence to both behavioral and medical interventions that specifically aimed at reducing the risk of spontaneous recurrent preterm births; Develop a platform that can capture participant behavior regarding the participant's lifestyle, environment, social factors, and personal health status; Allow participants to be co-creators of content, thus creating a support network. The investigators hope to achieve improvements in the following primary outcome: Inter-pregnancy interval and the following secondary outcomes: postpartum depression, infant-mother bonding and breast milk feeding between the control and the intervention groups. Ultimately, the investigators hope improvements in these outcomes will improve secondary prevention of preterm births and ultimately reduce infant mortality.

Additionally, PretermConnect will monitor mothers on their social circumstances, such as housing and food insecurity, family employment status, and perceived importance of recommended care for the baby's and the participant's own health.

The investigators also want to observe if a mobile-delivered health management approach can be more effective than a traditional paper-based health management plan in reducing the incidence of subsequent preterm births amongst individuals who have already had at least one preterm birth.

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
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Individuals with a mobile phone capable of downloading apps from the Apple App Store or Google Play.
  • Participants must consent to the study.
  • Women whose child is in the neonatal intensive care unit/nursery because the infant was born preterm.
  • Women 16-50 years of age
  • Women who can read, write and understand English
  • Site-specific additional recruitment criteria
  • UPMC Children's Hospital of Pittsburgh: Mothers whose babies have been in the neonatal intensive care unit for more than one month.
  • UPMC Magee-Womens Hospital: Mothers who have had a preterm baby of <36 weeks.

排除标准

  • For this initial study, those who do not have a mobile phone will be excluded. (This exclusion will not affect the inclusion of minorities as minorities Internet use via mobile platforms is equal to or greater than whites; hence we are not excluding minorities, based on the PEW Research Center study (PEW Internet Spring Tracking Survey, April 17-May 19, 2013)).
  • Women who have not previously had a preterm birth will be excluded as we are trying to reduce the risk of recurrent preterm birth.

结局指标

主要结局

Interpregnancy interval

时间窗: 12-months

Time interval from most recent birth to next conception

次要结局

  • Breastmilk feeding(12-months)
  • Mother-infant bonding(12-months)
  • Postpartum depression(12-months)

研究者

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

Jason Wang

PROFESSOR OF PEDIATRICS (GENERAL PEDIATRICS) AND HEALTH POLICY

Stanford University

研究点 (4)

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