PACTR201809756724274已完成3 期
A Randomised, Double-Blind, Placebo-Controlled Trial of the Effects of Selenium Supplementation on Pregnancy Outcome and Disease Progression in HIV-Infected Pregnant Women in Lagos, Nigeria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 13 Year(s) 至 18 Year(s)（—）
- 性别
- Female
入选标准
- •1. Pregnant women aged 15 to 49 years
- •2. Singleton gestation at 14 to 26 weeks’ gestation
- •3. On antiretroviral treatment (ART) for at least 3 months prior to enrolment.
排除标准
- •1. Multiple Gestations
- •2. Significant renal and hepatic impairment
- •3. An expected delivery date beyond March 2019
- •4. Mid-trimester pregnancy loss in the index pregnancy
- •5. Receipt of a long course of a mineral supplement containing selenium during the 6 months prior to enrolment
- •6. Refusal of consent at enrolment or withdrawal of consent during the study
- •7. Failure to receive the study intervention (selenium or placebo) for a cumulative period of at least 8 weeks before delivery.
- •8. To be excluded in the final analysis of the primary end-points (see below) are women who delivered by Caesarean section or those who had iatrogenic preterm delivery.
研究者
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