Postpartum FatiguePhase 4MFI20NCT07880314
Maternal Fatigue After Postpartum Anemia Treatment With Intravenous Ferric Carboxymaltose and Oral Iron Therapy
A Phase 4 study testing INTRAVENOUS FERRIC CARBOXYMALTOSE and oral iron therapy in people with Postpartum Fatigue and Iron Deficiency Anemia, run by Pakistan Air Force (PAF) Hospital Islamabad at 1 site in Pakistan.
Trial summary
Postpartum Anemia is common after childbirth and may contribute to tiredness and reduced wellbeing in mothers.This randomized controlled trial will compare two treatments for postpartum iron deficiency:intravenous ferric carboxymaltose and oral iron therapy .This study will assess whether intravenous ferric… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Fatigue, Iron Deficiency Anemia
- What is being tested?
- INTRAVENOUS FERRIC CARBOXYMALTOSE and oral iron therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Apr 2026to 20 Sep 2026
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 years
- Postpartum period (within 48 hours)
- Hemoglobin < 10 g/dL
- Singleton delivery
- Willing to participate Exclusion Criteria
- Severe anemia requiring blood transfusion
Show all 10Show fewer
- Known hemoglobinopathies
- Chronic medical illness (renal, hepatic, cardiac)
- Postpartum sepsis or PPH
- Previous iron therapy in current pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Fatigue After Postpartum Anemia Treatment With Intravenous Ferric Carboxymaltose Versus Oral Iron Therapy
Postpartum Anemia is common after childbirth and may contribute to tiredness and reduced wellbeing in mothers.This randomized controlled trial will compare two treatments for postpartum iron deficiency:intravenous ferric carboxymaltose and oral iron therapy .This study will assess whether intravenous ferric carboxymaltose provides greater improvement in maternal fatigue during the first 6 weeks after childbirth compared to oral iron.Secondary outcomes will be assessment of depressive symptoms and breastfeeding self efficacy .Eligible postpartum women with iron deficiency anemia will be randomly assigned to receive either intravenous ferric carboxymaltose or oral iron therapy and will be followed for six weeks.The study hypothesis is that intravenous ferric carboxymaltose will result in greater improvement in maternalfatigue and may also effect breastfeeding self efficacy .
Read the detailed description
Investigators will administer intravenous or oral iron therapy to two subgroups randomized and check maternal fatigue through multidimentional fatigue inventory MFI 20 at 48hrs and 2 week and 6 week postpartum ,and see whether fatigue score improved or not other outcome like edinberg postnatal depression scale , breastfeeding selfefficacy at 2 week and 6 week postpartum and assosciated sideeffects
- Conditions
- Postpartum Fatigue, Iron Deficiency Anemia
- Being tested
- INTRAVENOUS FERRIC CARBOXYMALTOSE, oral iron therapy
- Keywords
- postpartum anemia, postpartum fatigue, iron deficiency anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRAVENOUS FERRIC CARBOXYMALTOSEDrug
Intravenous ferric carboxymaltose is administered as a single dose according to calculated iron deficit within 48hrs after postpartum
oral iron therapyDrug
participants will receive oral ferrous sulphate tablets providing 200mg elemental iron daily till required
| Study group | Role | What they receive |
|---|---|---|
| INTRAVENOUS FERRIC CARBOXYMALTOSE group | Experimental | single dose Intravenous ferric carboxymaltose administered postpartum Receives: Drug: INTRAVENOUS FERRIC CARBOXYMALTOSE |
| oral iron therapy group | Active comparator | oral iron therapy to treat anemia as comparative group Receives: Drug: oral iron therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in Maternal fatigue total score on the Multidimensional fatigue inventory
Maternal fatigue is assessed using Multidimensional Fatigue inventory ,a 20 item self report questionnaire . Each item is rated on 5 point likert scale 1 to 5 .The total fatigue score is calculated by summing all 20 items ,yielding a minimum 20 and maximum score of 100. Higher score represent greater fatigue severity ,indicating a worse clinical outcome. change from baseline is calculated as the post treatment score minus the baseline score
Measured: baseline, 2 week , 6 weeks post treatment
Secondary outcomes (3)
change from baseline in breastfeeding self efficacy scale short form score
Breastfeeding self efficacy assesed through breastfeeding self efficacy scale short form ,a 14 item self report questionaire .Each item is rated on 5 point likert scale ranging from 1( not at all) to 5 (always confident ) .Total scores are derived by summing all 14 item responses, yielding a minimum score of 14 and maximum score of 70 .Higher score means greater breastfeeding self efficacy indicating a better clinical outcome change from baseline is calculated as followup score minus baseline score
Measured: baseline 2 week and 6 week postpartum
number of participants with treatment emergent adverse effects
safety and tolerability are evaluated by systemically recording all treatment emergent adverse effects and side effects following iron administration, adverse events are monitored by type severity and potential causal relationship to study intervention. .
Measured: 2 week and 6 week posttreatment
change from baseline in depressive symptoms on the Edinberg postnatal depression scale
Maternal depressive symptoms were assessed using edinberg postnatal depression scale ,a 10 item likert self report questionaire . Each item is score on 4 point scale ranging from 0 to 3 .The total score is calculated by summing 10 items yielding a minimum score of 0 and highest score of 30 .Higher total score represent greater severity of depressive symptoms
Measured: baseline ,2 weeks and 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 posted19 Oct 2026
- Study start20 Apr 2026
- Primary completion20 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum FatigueStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Air Force (PAF) Hospital Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afia Ayyaz, Pakistan Air Force (PAF) Hospital Islamabad
- Investigators
- afia ayyaz, mbbs, Principal investigator, PAF hospital islamabadshamsa rizwan, FCPS, Study director, PAF hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880314
- Sponsor's protocol ID
- OBGYN -PPA-IRON-MFI-20-2026
- Acronym
- MFI20
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bombac Tavcar L, Hrobat H, Gornik L, Preloznik Zupan I, Vidmar Simic M, Peclin P, Kavsek G, Lucovnik M. Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial. J Clin Med. 2024 Jan 28;13(3):758. doi: 10.3390/jcm13030758.
PubMed 38337452
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Fatigue After Postpartum Anemia Treatment With Intravenous Ferric Carboxymaltose Versus Oral Iron Therapy
- ClinicalTrials.gov ID
- NCT07880314
- Acronym / sponsor ID
- MFI20 / OBGYN -PPA-IRON-MFI-20-2026
- Conditions
- Postpartum Fatigue, Iron Deficiency Anemia
- Keywords
- postpartum anemia, postpartum fatigue, iron deficiency anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Pakistan Air Force (PAF) Hospital IslamabadUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 19 Oct 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 common after childbirth and may contribute to tiredness and reduced wellbeing in mothers.This randomized controlled trial will compare two treatments for postpartum iron deficiency:intravenous ferric carboxymaltose and oral iron therapy .This study will assess whether intravenous ferric carboxymaltose provides greater improvement in maternal fatigue during the first 6 weeks after childbirth compared to oral iron.Secondary outcomes will be assessment of depressive symptoms and breastfeeding self efficacy .Eligible postpartum women with iron deficiency anemia will be randomly assigned to receive either intravenous ferric carboxymaltose or oral iron therapy and will be followed for six weeks.The study hypothesis is that intravenous ferric carboxymaltose will result in greater improvement in maternalfatigue and may also effect breastfeeding self efficacy .
Detailed description
Investigators will administer intravenous or oral iron therapy to two subgroups randomized and check maternal fatigue through multidimentional fatigue inventory MFI 20 at 48hrs and 2 week and 6 week postpartum ,and see whether fatigue score improved or not other outcome like edinberg postnatal depression scale , breastfeeding selfefficacy at 2 week and 6 week postpartum and assosciated sideeffects
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTRAVENOUS FERRIC CARBOXYMALTOSE group | Experimental | Drug: INTRAVENOUS FERRIC CARBOXYMALTOSEsingle dose Intravenous ferric carboxymaltose administered postpartum |
| oral iron therapy group | Active comparator | Drug: oral iron therapyoral iron therapy to treat anemia as comparative group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Women aged 18-45 years
- Postpartum period (within 48 hours)
- Hemoglobin < 10 g/dL
- Singleton delivery
- Willing to participate Exclusion Criteria
Key exclusion criteria (0 listed)
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 FERRIC CARBOXYMALTOSEIntravenous ferric carboxymaltose is administered as a single dose according to calculated iron deficit within 48hrs after postpartum | Drug | INTRAVENOUS FERRIC CARBOXYMALTOSE group |
| oral iron therapyparticipants will receive oral ferrous sulphate tablets providing 200mg elemental iron daily till required | Drug | oral iron therapy group |
Primary outcome
change from baseline in Maternal fatigue total score on the Multidimensional fatigue inventory
Time frame: baseline, 2 week , 6 weeks post treatment
Maternal fatigue is assessed using Multidimensional Fatigue inventory ,a 20 item self report questionnaire . Each item is rated on 5 point likert scale 1 to 5 .The total fatigue score is calculated by summing all 20 items ,yielding a minimum 20 and maximum score of 100. Higher score represent greater fatigue severity ,indicating a worse clinical outcome. change from baseline is calculated as the post treatment score minus the baseline score
3 secondary outcomes
change from baseline in breastfeeding self efficacy scale short form score
Time frame: baseline 2 week and 6 week postpartum
number of participants with treatment emergent adverse effects
Time frame: 2 week and 6 week posttreatment
change from baseline in depressive symptoms on the Edinberg postnatal depression scale
Time frame: baseline ,2 weeks and 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 19 Oct 2026.
- Results publication: PubMed 38337452Bombac Tavcar L, Hrobat H, Gornik L, Preloznik Zupan I, Vidmar Simic M, Peclin P, Kavsek G, Lucovnik M. Maternal Fatigue after Postpartum Anemia Treatment with Intravenous Ferric Carboxymaltose vs. Intravenous Ferric Derisomaltose vs. Oral Ferrous Sulphate: A Randomized Controlled Trial. J Clin Med. 2024 Jan 28;13(3):758. doi: 10.3390/jcm13030758.
- 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.
afia ayyaz, mbbs principal investigator
PAF hospital islamabad
shamsa rizwan, FCPS study director
PAF hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing INTRAVENOUS FERRIC CARBOXYMALTOSE and oral iron therapy in people with Postpartum Fatigue and Iron Deficiency Anemia, run by Pakistan Air Force (PAF) Hospital Islamabad 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 10 inclusion and 0 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 19 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change from baseline in Maternal fatigue total score on the Multidimensional fatigue inventory (time frame: baseline, 2 week , 6 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07880314, which also lists 1 linked publication.
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 19 Oct 2026.