To assess the effectiveness of iron supplementation with Speedral Capsule in pregnant wome

Not Applicable

Completed

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

• Registration Number: CTRI/2022/04/041690
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-17
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 195

Inclusion Criteria

(1.) Pregnant women with age between 20 and 40 years (2.) Subjects who received iron supplements in the form of Speedral capsule for greater than equal to 3 months during pregnancy at period of gestation greater than equal to 12 weeks (3.) Singleton pregnancy

Exclusion Criteria

1. Subjects with recent history of blood transfusion

2. Subjects with malabsorptive and restrictive bariatric surgery

3. Subjects with inflammatory bowel disease, irritable bowel syndrome, celiac disease,

atrophic gastritis, Helicobacter pylori or any active infection

4. Subjects receiving any iron supplementation other than Speedral Capsule

5. Subjects with Folate or Vitamin B12 deficiency anemia, sideroblastic anemia,

thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, and anemia of

chronic disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent change in hemoglobin from baselineTimepoint: Percent change in hemoglobin from baseline to greater than equal to 3 months of supplementation

Secondary Outcome Measures

Name	Time	Method
1. Percentage of subjects having hemoglobin greater than equal to 10.5 g/dl <br/ ><br>2. Percentage of subjects having hemoglobin greater than equal to 11 g/dl <br/ ><br>3. Percentage of subjects having serum ferritin greater than equal to 30 ng/dl OR micrograms/L <br/ ><br>4. All recorded adverse even or SAETimepoint: Time frame: greater than equal to 3 months of supplementation <br/ ><br>Time frame: greater than equal to 3 months of supplementation <br/ ><br>Time frame: greater than equal to 3 months of supplementation <br/ ><br>Time frame: from initiation of supplementation to greater than equal to 3 months of supplementation