Postpartum AnaemiaPhase 1/2NCT07110935
Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron in a Tertiary Hospital in South East, Nigeria.
A Phase 1/2 study testing intravenous iron and oral iron in people with Postpartum Anaemia, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
Background:Anaemia is a condition of public health importance.Iron deficiency anaemia is the most common cause of anaemia in pregnancy.Postpartum anaemia poses a significant role for postpartum morbidity and mortality and should be treated.Postpartum iron deficiency anaemia warrants greater attention and higher… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Postpartum Anaemia
- What is being tested?
- intravenous iron and oral iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteNigeria
- Study dates
- 13 Sep 2018to 20 Feb 2019
- Phase
- Phase 1/2
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who have vaginal delivery of singleton baby and are seen within 48hours of childbirth
- Women with mild and moderate anaemia
- Women who gave their consent to participate in the study.
Who cannot join
- Women with severe anaemia
- Women with multiple pregnancy
- Women with genotype HbSS
- Women with HIV infection
- Women who delivered by caesarean section
- Women with co-morbidity like hypertensive disorders, renal pathology
- Women who decline consent after adequate counseling.
- Previous and current history of adverse reaction to iron dextran
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron
Background:Anaemia is a condition of public health importance.Iron deficiency anaemia is the most common cause of anaemia in pregnancy.Postpartum anaemia poses a significant role for postpartum morbidity and mortality and should be treated.Postpartum iron deficiency anaemia warrants greater attention and higher quality of care.Oral iron treatment has been considered the standard of care.
However,parenteral iron treatment is expected to be advantageous in cases where oral iron therapy is not possible.As a result,there is increased interest in parenteral iron therapy.
Read more
Objectives:To determine the effect of treatment of postpartum anaemia with intravenous versus oral iron therapy at Federal Medical Centre,Umuahia.
Materials and Method:This study is a prospective randomized controlled study carried out in department of Obstetric and Gynaecology, Federal Medical Centre,Umuahia,the capital of Abia State,South-east, Nigeria. The study population comprised of postpartum women with mild to moderate anaemia within 48 hours of delivery who were randomized into two groups.One group will be given oral iron therapy and the other intravenous iron dextran.Response and comparative effects of treatment using either route of administration were assessed at 6 weeks postpartum.The biodata,obstetric characteristics and haemoglobin estimation of the respondents were recorded on a structured study proforma.The data obtained from the study was analyzed with the statistical package for the social sciences(SPSS) software.Continuous variables obtained from this study were expressed as mean and standard deviation while categorical variables were summarized using frequency and percentages.Association between categorical variables were done using chi square.P-value less than 0.05 was taken as significant.
- Conditions
- Postpartum Anaemia
- Being tested
- intravenous iron, oral iron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ironDrug
intravenous iron dextran
oral ironDrug
oral iron(ferrous Sulphate)
| Study group | Role | What they receive |
|---|---|---|
| One hundred and forty five women who picked "i" were assigned intravenous iron therapy group | Experimental | Not described Receives: Drug: intravenous iron |
| One hundred and forty five women who picked "o" were assigned oral iron therapy group | Active comparator | Not described Receives: Drug: oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postpartum haematocrit
Measured: Six weeks
Mean hematocrit following treatment with iron dextran
Measured: Six weeks
Secondary outcomes (1)
Incidence and patterns of postpartum anaemia
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start13 Sep 2018
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110935
- Sponsor's protocol ID
- FMC/QEH/G.596/Vol.10/266
- Status last verified
- Aug 2025
- First submitted
- 27 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment of Postpartum Anaemia With Intravenous Iron Versus Oral Iron
- ClinicalTrials.gov ID
- NCT07110935
- Acronym / sponsor ID
- FMC/QEH/G.596/Vol.10/266
- Conditions
- Postpartum Anaemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 8 Aug 2025 (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.
Background:Anaemia is a condition of public health importance.Iron deficiency anaemia is the most common cause of anaemia in pregnancy.Postpartum anaemia poses a significant role for postpartum morbidity and mortality and should be treated.Postpartum iron deficiency anaemia warrants greater attention and higher quality of care.Oral iron treatment has been considered the standard of care.
However,parenteral iron treatment is expected to be advantageous in cases where oral iron therapy is not possible.As a result,there is increased interest in parenteral iron therapy.
Objectives:To determine the effect of treatment of postpartum anaemia with intravenous versus oral iron therapy at Federal Medical Centre,Umuahia.
Materials and Method:This study is a prospective randomized controlled study carried out in department of Obstetric and Gynaecology, Federal Medical Centre,Umuahia,the capital of Abia State,South-east, Nigeria. The study population comprised of postpartum women with mild to moderate anaemia within 48 hours of delivery who were randomized into two groups.One group will be given oral iron therapy and the other intravenous iron dextran.Response and comparative effects of treatment using either route of administration were assessed at 6 weeks postpartum.The biodata,obstetric characteristics and haemoglobin estimation of the respondents were recorded on a structured study proforma.The data obtained from the study was analyzed with the statistical package for the social sciences(SPSS) software.Continuous variables obtained from this study were expressed as mean and standard deviation while categorical variables were summarized using frequency and percentages.Association between categorical variables were done using chi square.P-value less than 0.05 was taken as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One hundred and forty five women who picked "i" were assigned intravenous iron therapy group | Experimental | Drug: intravenous iron |
| One hundred and forty five women who picked "o" were assigned oral iron therapy group | Active comparator | Drug: oral iron |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who have vaginal delivery of singleton baby and are seen within 48hours of childbirth
- Women with mild and moderate anaemia
- Women who gave their consent to participate in the study.
Key exclusion criteria (8 listed)
- Women with severe anaemia
- Women with multiple pregnancy
- Women with genotype HbSS
- Women with HIV infection
- Women who delivered by caesarean section
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 |
|---|---|---|
| intravenous ironintravenous iron dextran | Drug | One hundred and forty five women who picked "i" were assigned intravenous iron therapy group |
| oral ironoral iron(ferrous Sulphate) | Drug | One hundred and forty five women who picked "o" were assigned oral iron therapy group |
Primary outcome
Mean postpartum haematocrit
Time frame: Six weeks
Mean hematocrit following treatment with iron dextran
Time frame: Six weeks
1 secondary outcome
Incidence and patterns of postpartum anaemia
Time frame: Six weeks
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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 Phase 1/2 study testing intravenous iron and oral iron in people with Postpartum Anaemia, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
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 3 inclusion and 8 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 8 Aug 2025. 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 Nigeria. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean postpartum haematocrit (time frame: Six weeks). The study lists 2 primary outcomes in all. 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 8 Aug 2025.