PACTR201808177464681招募中4 期
Reduction of low birth weight at delivery through the adjunction of oral azithromycin to the intermittent preventive treatment of malaria in pregnant women: a randomized controlled trial in rural Burkina Faso
clinical research unit of nanoro0 个研究点目标入组 942 人开始时间: 2018年7月31日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 942
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
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- Female
入选标准
- •1. Being a pregnant woman between 16 and 32 weeks of pregnancy
- •2. At least 15 years old; and under 44 years old
- •3. Residence within the health facility catchment’s area,
- •4. Willingness to deliver at the health facility;
- •5. Willingness to adhere to the study protocol requirements;
- •6. Ability to provide written informed consent.
排除标准
- •1. History of allergic reactions to the study drugs;
- •2. History of known pregnancy complications or bad obstetric history such as repeated stillbirths or eclampsia;
- •3. History or presence of major illnesses likely to influence pregnancy outcome including diabetes mellitus, severe renal or heart disease, or active tuberculosis;
- •4. Multiple pregnancies (i.e. twin/triplets);
- •5. Current cotrimoxazole prophylaxis or anti-retroviral therapy (ART);
- •6. Any significant ongoing condition that requires hospitalization, including severe malaria;
- •7. Intent to move out of the study catchment area before delivery or deliver at relative’s home out of the catchment area;
- •8. Prior enrollment in the study or concurrent enrollment in another study;
- •9. Unable to take oral medication;
- •10. Clear evidence of recent treatment with artemisinin based combination treatment (ACT), SP or azithromycin during the first trimester of pregnancy, etc.
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