Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Number of Congenital birth defects
研究概览
简要总结
The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.
详细描述
Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.
The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV positive pregnant woman on antiretroviral treatment
- •Able and willing to participate and provide informed consent
- •Be at least 18 years of age or older than legal age to provide consent
- •If under legal age, must have legal guardian who is able to give consent
- •Be an emancipated minor
排除标准
- •History of mental illness
- •History of condition that would preclude provision of consent
- •Inability to provide consent
结局指标
主要结局
Number of Congenital birth defects
时间窗: At birth
Number of congenital birth defects among infants born in the study
次要结局
- Adverse Pregnancy outcomes(At outcome of pregnancy)