Study of Iron supplement in anemic pregnant women.

Phase 3

• Conditions: Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium

• Registration Number: CTRI/2024/06/069166
• Lead Sponsor: Generex Pharmassist Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified