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

Effectiveness and Tolerability of Oral Iron Supplementation in Pregnant Womenâ?? A Retrospective, Real-World Evidence Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/041690
Enrollment
195
Registered
2022-04-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

Sun Pharma Laboratories Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Percent change in hemoglobin from baselineTimepoint: Percent change in hemoglobin from baseline to greater than equal to 3 months of supplementation—

Secondary

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

Countries

India

Contacts

Public ContactDr Srivani Palukuri

Sekhmet Technologies Private Limited(THB)

srivani@thb.co.in9560020029

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026