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临床试验/NCT00271960
NCT00271960已完成3 期

Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women

Yale University4 个研究点 分布在 1 个国家目标入组 1,047 人开始时间: 2001年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,047
试验地点
4
主要终点
Sexual risk behavior

研究概览

简要总结

This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.

详细描述

Millions of young adults become infected with sexually transmitted diseases (STDs) each year. Young adults are particularly vulnerable to STD infection because most are not educated about STDs and use condoms improperly or inconsistently. Transmission of STDs from a pregnant woman to her baby can occur before, during, or after birth. It is, therefore, particularly important to educate young pregnant women about STDs.

Group prenatal care may be a beneficial way to assist young women. It would allow increased contact with care providers, integrate the complex needs of pregnant women, and provide support services. This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV and other STDs in young women during and after pregnancy.

Participants in this unblinded study will be randomly assigned to one of three groups: standard individual prenatal care; standard CenteringPregnancy group prenatal care; or CenteringPregnancy Plus (CP+) group prenatal care. All participants assigned to either CenteringPregnancy or CP+ will have an initial individual medical exam. Groups will be formed based on participants' estimated delivery months, and will be led by a trained independent practitioner. There will be ten 2-hour group sessions between Weeks 16 and 40 of pregnancy. At each session, participants will first weigh themselves and take their blood pressure to chart their own progress. Individual prenatal assessments lasting approximately 30 minutes will be conducted by the practitioner. Participants will then have time to fill out handouts and self-assessments and engage in discussion with other group members. Discussions will focus on education and building prenatal, childbirth, and parenting skills. The CP+ sessions will include an HIV/STD risk reduction component in addition to all the elements of the standard CenteringPregnancy program. This additional feature will consist of interactive discussion, exercises, and skill-building activities targeted towards reducing HIV/STD risk behaviors. Participants assigned to receive standard individual prenatal care will not participate in group sessions, but will receive standard prenatal care. Outcome measures will include incidence of STD infection, rapid repeat pregnancy, degree of sexual risk behavior, perinatal and psychosocial factors.

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
14 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant and currently at less than 24 weeks gestation
  • English- or Spanish-speaking
  • Willing to be randomly assigned to either group or individual prenatal care

排除标准

  • Any severe medical problems requiring individualized assessment and tracking as a "high-risk pregnancy" (e.g., active substance use, mental illness, HIV)

结局指标

主要结局

Sexual risk behavior

时间窗: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

Sexually transmitted disease

时间窗: Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum

Perinatal outcomes (e.g., birth weight, gestational age)

时间窗: Measured at Months 6 and 12 postpartum

Rapid repeat pregnancy

时间窗: Measured at Month 12 postpartum

次要结局

  • Psychosocial factors (e.g., depression, stress, social support)(Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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