Reducing Preterm Births in Underserved Pregnant Women
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
- 是
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
James G. Christian
President
PHCC LP
