Parasitic Infection in Anemic Pregnant Women. Prevalence and Effects in Rural Area in Egypt.
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- correction of naemia
研究概览
简要总结
Women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dL.
详细描述
All patients in the study were subjected to:
- Detailed history was recorded. A proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. Participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, Diet, and information useful to determine the socioeconomic level was recorded. Information on previous pregnancies and children and history of chronic diseases were also recorded.
- General examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant.
- Diagnosis of anemia by Complete blood count (CBC), Hb level and measuring hematocrit concentration.
- Diagnosis of parasitic infection by stool analysis using suitable techniques.
- Imaging including obstetric ultrasound (U/S) to assess fetal development.
- Women with helminthic infections will be divided into groups
Group (A): received iron + antiparasitic treatment as follows:
- Patients who have STH received alzental 200mg tab 2 tabs single oral dose.
- Patients who have Entamoeba or Giardia received flagyl 500mg tab twice daily for 5 days.
- (B): received iron only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound)
- •hemoglobin level below 10.5 mg /dL
排除标准
- •women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders
- •women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis.
- •Women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded
研究组 & 干预措施
Anemia without parasitic infection
women with anemia without parasitic infection will receive iron treatment
干预措施: Iron Supplement (Drug)
parasitic infection treated with iron
women with anemia with parasitic infection will receive oral iron treatment
干预措施: Iron Supplement (Drug)
parasitic infection treated with iron and antihelmemsic
women with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab
干预措施: Iron Supplement (Drug)
parasitic infection treated with iron and antihelmemsic
women with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab
干预措施: Metronidazole Oral (Drug)
parasitic infection treated with iron and antihelmemsic
women with anemia with parasitic infection will receive oral iron treatment and antihelminsic treatment in the form of metronidazole 500mg tab twice daily for 5 days in cases with Entamoeba or Giardia or albendazol 200mg tab
干预措施: Albendazole (Drug)
结局指标
主要结局
correction of naemia
时间窗: 6 weeks after treatment
hemoglobin level increased above 11 gm/dL
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
PROFESSOR
Cairo University