Monthly Versus Two Doses of Ante-Natal Intermittent Preventive Treatment With Sulphadoxine-Pyrimethamine in University College Hospital
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 136
- 主要终点
- Level of malaria parasitemia among pregnant women with monthly doses of sulphadoxine-pyrimethamine as compared to pregnant women with 2 doses of Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTp-SP).
研究概览
简要总结
Randomized controlled prospective comparative study
详细描述
This study is intended to be a randomized controlled comparative study conducted to compare the effect of monthly versus two doses of ante-natal intermittent preventive treatment with sulphadoxine-pyrimethamine
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women
- •Gestational age between 16 and 28weeks.
- •No history of use of sulphadoxine-pyrimethamine prior to recruitment
- •Not on any medication for prophylaxis
排除标准
- •HIV positive women
- •Pre-existing medical conditions e.g diabetes mellitus, haemoglobinopathy, hypertension, kidney disease, heart disease, any endocrine disorder like hypo/hyperthyroidism, Cushing' disease, connective tissue disorders like systemic lupus erythematosus, antiphospholipid syndrome or any otherautoimmune disease with poor feto-maternal outcomes in pregnancy.
- •History of Glucose -6-Phosphate Dehydrogenase (G6PD) deficiency in patient
- •Allergy to sulphonamides or pyrimethamine.
- •Non consenting patients
- •Multiple gestations
研究组 & 干预措施
Two doses of sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken twice before delivery
干预措施: Sulphadoxine-pyrimethamine (Drug)
Monthly doses of sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets taken monthly delivery
干预措施: Sulphadoxine-pyrimethamine (Drug)
结局指标
主要结局
Level of malaria parasitemia among pregnant women with monthly doses of sulphadoxine-pyrimethamine as compared to pregnant women with 2 doses of Intermittent Preventive Treatment of Malaria during Pregnancy with Sulphadoxine-Pyrimethamine (IPTp-SP).
时间窗: 4 Months
Number of participants with high level of malaria parasitemia in monthly doses of sulphadoxine-pyrimethamine group will be compared with the number of participants in 2 doses of IPTp-SP group.
次要结局
- Prevalence of drug related adverse events associated with multiple doses of sulphadoxine pyrimethamine.(4 Months)
研究者
Olaolu Olayinka ONI
Principal Investigator
University College Hospital, Ibadan