An open-label, randomized, parallel arm, comparative clinical study to evaluate efficacy of iron supplement formulations in pregnant women affected by iron deficiency anemia. - NI

Generex Pharmassist Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•Participants meeting all of the following criteria will be eligible for the study: 1. Pregnant females with the age between 20-35 years (both inclusive); 2. Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between the week 13 to week 16 (both inclusive); 3. Female with primi or multigravida; 4. Pregnant females without any other comorbidity; 5. Hemoglobin levels between 9-10.5 g/dl (both inclusive); 6. With or without fatigue associated with anemia; 7. Serum ferritin levels below 15 mcg/L; 8. Able to give written informed consent; 9. Able to follow up through visits.

•Participants meeting any of the following criteria will not be eligible for the study: 1. Pregnant women of less than 13 weeks and more than 16 weeks of gestation; 2. Pregnant female with complicated pregnancy history or ongoing treatment for the same; 3. Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia,
•hypothyroidism, hyperthyroidism and multiple pregnancy; 4. Fetal anomaly if detectable when an initial ultrasound is done to date
•the pregnancy; 5. Participants on any concomitant therapy for treating IDA during study period; 6. Not willing to provide consent or follow up; 7. Any condition from investigator viewpoint can affect participant participation in the study.

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