Does Eradication of H-pylori in Pregnant Patients With Iron Deficiency Anemia Have an Effect on Iron Replacement Therapy?
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- hemoglobin levels
研究概览
简要总结
the effect of eradication of H-pylori in pregnant patients with iron deficiency anemia on the level of hemoglobin after iron therapy.
详细描述
After approval of the "Ethics Committee" of the obstetrics and gynecology department of the faculty of medicine Cairo University, a clinical trial will be started in which pregnant patients with iron deficiency anemia will be recruited out of the antenatal care clinic. Routine complete blood count (CBC) is done early during the second trimester for cases with anemia discovered by labs drawn on their booking appointment during their 1st antenatal care visit.
IDA defined as hemoglobin below 11gm/dl with MCV below 80 fl, with one of the following: if the serum ferritin level is below 70 μg/L. or if transferrin saturation is below 20.
We based our sample size according to the work done by Nashaat & Mansour, 2014 who studied a difference in the mean hemoglobin level of 1.6 g/dl with a standard deviation of 3.3. The ratio of women in the control group to experimental group was set at 1:1, the power at 0.8, and the type I error at 0.05 which gave us 68 subjects in every arm. We allowed for 10% dropouts finally giving us 75 subjects on each study arm.
After obtaining informed consent, H-pylori infection will be diagnosed using a stool antigen assay ABON which is one step H. pylori antigen test device (®Inverness Medical Innovation Hong Kong Limited). A stool sample will be collected and the top screwed on. An applicator will then be introduced into the sample after unscrewing of the cap in three different sites to collect at least 50 mg of fecal matter. The sample will be centrifuged at 4000 rpm for 5 minutes and the supernatant will be used for immunoassay. Two drops will be placed on the kit as per kit instructions. This test utilizes lateral chromatographic assay where after 10 minutes a positive sample will have a purple-pink line in addition to the control line, while a negative test only has the control line present. If the control line was missing the test will be considered invalid.
All the enrolled participants will then be randomized into two groups using a computer generated randomization table and a sealed envelope system to be opened by the nurse in the next antenatal care visit. When the envelope is opened the participant will be assigned to either group (A) (eradication of H-pylori before iron therapy) or group (B) (start iron therapy without eradication o f H-pylori).
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
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosed Iron deficiency anemia.
- •H-pylori positive cases.
- •Second trimester pregnancy.
排除标准
- •Severe Iron deficiency anemia (hemoglobin < 8.0 g/dL).
- •Parasitic worm infection e.g. schistosomiasis, and hook worm by stool analysis.
- •Any cases giving clinical symptoms of gastritis e.g. nausea, vomiting, dull aching pain or soreness in the epigastrium.
- •Cases with history of gastric ulcer diagnosed by upper endoscopy.
- •Cases complaining of hematemesis.
研究组 & 干预措施
Eradication of H-pylori
triple attack therapy (Clarithromycin 500 mg BID for 14 days, omeprazole 20 mg BID for 14 days, metronidazole 500 mg BID for 14 days).
Followed by confirmation of eradication by repeating the H-pylori stool antigen test.
Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
干预措施: triple attack therapy (Drug)
Eradication of H-pylori
triple attack therapy (Clarithromycin 500 mg BID for 14 days, omeprazole 20 mg BID for 14 days, metronidazole 500 mg BID for 14 days).
Followed by confirmation of eradication by repeating the H-pylori stool antigen test.
Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
干预措施: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules (Drug)
No eradication of H-pylori
Iron therapy will be given twice daily for one month in the form ferrous(II)-glycine-sulphate complex 567.7 mg capsules (each capsule contains about 100 mg elemental iron) Ferro sanol duodenal ®Minapharm, Egypt.
干预措施: Ferrous(II)-glycine-sulphate complex 567.7 mg capsules (Drug)
结局指标
主要结局
hemoglobin levels
时间窗: one month
difference in mean mean hemoglobin levels
次要结局
未报告次要终点
研究者
Ahmed M.Kamel
Assistant professor of obstetrics and gynecology
Kasr El Aini Hospital