Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia

Postpartum anemia is a common condition associated with adverse maternal outcomes. This study aimed to compare the effectiveness of oral iron therapy versus intravenous iron therapy in women with postpartum anemia.

Study Overview

• Status: Completed
• Conditions: Postpartum Anaemia
• Intervention / Treatment: Drug: Ferric Carboxy Maltose; Drug: Ferrous Sulfate

Detailed Description

This randomized, open-label, parallel-group study was conducted at Shahida Islam Medical College and Hospital, Lodhran, Pakistan. Women diagnosed with postpartum anemia who fulfilled the eligibility criteria were randomly allocated using a lottery method to receive either intravenous iron (ferric carboxymaltose) or oral iron therapy (ferrous sulfate). The primary outcome was the change in hemoglobin level from baseline to 6 weeks of follow-up.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lodhrān, Punjab Province, Pakistan
      • Shahida Islam Medical College and Hospital, Lodhran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. All women with postpartum anaemia as per operational definition i.e Haemoglobin <11 g/dl at 24 hours after delivery (either caesarean or SVD).
2. Age 20-40 years.
3. BMI 19-25.
4. Pre-operative haemoglobin >10 g/dl.
5. Both primiparous and multiparous.

6. Both primigravida and multigravida.

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Exclusion Criteria:

1. Iron Intolerance or previous history of allergy to iron
2. Parenteral Iron hypersensitivity
3. Patients with thalassemia
4. Indication of blood transfusion
5. Patients with bleeding/ clotting disorders
6. Patients with postpartum haemorrhage
7. Patients with chronic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Intravenous Iron Therapy; Participants received intravenous iron therapy for the treatment of postpartum anemia	Drug: Ferric Carboxy Maltose; Participants received Intravenous iron i.e ferric carboxymaltose (≤1,000 mg) were given to patients in Group "A" either as a single dose or as two doses spaced three days apart in 100 milliliters of 0.9% normal saline during a half-hour period.
Experimental: Group B: Oral Iron Therapy; Participants received oral iron therapy for the treatment of postpartum anemia.	Drug: Ferrous Sulfate; Participants given tablet Ferrous sulfate, 325 mg orally three times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in hemoglobin level	Baseline to 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Shahida Islam Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2025
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: ferrous sulfate
• Other Study ID Numbers: SIMC-postpartumanemia-2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No