Postpartum AnaemiaNCT07340450
Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia
A study testing Ferric Carboxy Maltose and Ferrous Sulfate in people with Postpartum Anaemia, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Anaemia
- What is being tested?
- Ferric Carboxy Maltose and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Feb 2025to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All women with postpartum anaemia as per operational definition i.e Haemoglobin <11 g/dl at 24 hours after delivery (either caesarean or SVD).
- Age 20-40 years.
- BMI 19-25.
- Pre-operative haemoglobin >10 g/dl.
- Both primiparous and multiparous.
- Both primigravida and multigravida.
- -
Who cannot join
- Iron Intolerance or previous history of allergy to iron
- Parenteral Iron hypersensitivity
- Patients with thalassemia
- Indication of blood transfusion
- Patients with bleeding/ clotting disorders
- Patients with postpartum haemorrhage
- Patients with chronic diseases.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shahida Islam Medical College and Hospital, Lodhran
Lodhrān, Punjab Province
About this study
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.
Read the 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.
- Conditions
- Postpartum Anaemia
- Being tested
- Ferric Carboxy Maltose, Ferrous Sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxy MaltoseDrug
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.
Ferrous SulfateDrug
Participants given tablet Ferrous sulfate, 325 mg orally three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Intravenous Iron Therapy | Experimental | Participants received intravenous iron therapy for the treatment of postpartum anemia Receives: Drug: Ferric Carboxy Maltose |
| Group B: Oral Iron Therapy | Experimental | Participants received oral iron therapy for the treatment of postpartum anemia. Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level
Measured: Baseline to 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start18 Feb 2025
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidra Jalil Khan, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340450
- Sponsor's protocol ID
- SIMC-postpartumanemia-2025
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral vs Intravenous Iron Therapy for the Treatment of Postpartum Anemia
- ClinicalTrials.gov ID
- NCT07340450
- Acronym / sponsor ID
- SIMC-postpartumanemia-2025
- Conditions
- Postpartum Anaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Intravenous Iron Therapy | Experimental | Drug: Ferric Carboxy MaltoseParticipants received intravenous iron therapy for the treatment of postpartum anemia |
| Group B: Oral Iron Therapy | Experimental | Drug: Ferrous SulfateParticipants received oral iron therapy for the treatment of postpartum anemia. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All women with postpartum anaemia as per operational definition i.e Haemoglobin <11 g/dl at 24 hours after delivery (either caesarean or SVD).
- Age 20-40 years.
- BMI 19-25.
- Pre-operative haemoglobin >10 g/dl.
- Both primiparous and multiparous.
Key exclusion criteria (7 listed)
- Iron Intolerance or previous history of allergy to iron
- Parenteral Iron hypersensitivity
- Patients with thalassemia
- Indication of blood transfusion
- Patients with bleeding/ clotting disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxy MaltoseParticipants 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. | Drug | Group A: Intravenous Iron Therapy |
| Ferrous SulfateParticipants given tablet Ferrous sulfate, 325 mg orally three times a day. | Drug | Group B: Oral Iron Therapy |
Primary outcome
Change in hemoglobin level
Time frame: Baseline to 6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric Carboxy Maltose and Ferrous Sulfate in people with Postpartum Anaemia, run by Shahida Islam Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin level (time frame: Baseline to 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.