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临床试验/NCT01344616
NCT01344616已完成2 期

Reducing Preterm Births in Underserved Pregnant Women

PHCC LP2 个研究点 分布在 1 个国家目标入组 482 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
482
试验地点
2
主要终点
Birthweight

研究概览

简要总结

Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex. If the proposed system proves to be effective in reducing preterm births it can improve maternal and child quality of life as well as reduce the economic burden of preterm births in the U.S.

详细描述

The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted intervention system to significantly reduce preterm births in high-risk populations. This system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated with increased risks of preterm birth including smoking cessation, poor nutrition, domestic violence, maternal depression and stress, urinary and reproductive tract infections and substance use; (2) provide her with tailored advice and action planning tools on reducing her risks; (3) provide her certified nurse midwife or physician with information related to her assessed risks and counseling suggestions tailored for her needs, and [(4) promote effective referrals to, and successful linkages with community-based support organizations.] Because preterm birth rates are much higher for underserved African American women, we are proposing to focus the intervention with this population.

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 48 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Study inclusion criteria include:
  • age 16-48 years,
  • 1st trimester of pregnancy,
  • race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.

排除标准

  • Exclusion criteria include:
  • a medical condition or risk to the pregnancy that the physician or nurse midwife determines serious and a reason for exclusion, and
  • a literacy level of < grade
  • No prior experience using a computer is needed. -

结局指标

主要结局

Birthweight

时间窗: 9 months

Birth weight \< 2500 grams

次要结局

  • Gestational Weight(9 months)

研究者

发起方
PHCC LP
申办方类型
Industry
责任方
Principal Investigator
主要研究者

James G. Christian

President

PHCC LP

研究点 (2)

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