Maternal Fatigue After Postpartum Anemia Treatment With Intravenous Ferric Carboxymaltose and Oral Iron Therapy

THE STUDY

About this study

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 .

Full official title

Maternal Fatigue After Postpartum Anemia Treatment With Intravenous Ferric Carboxymaltose Versus Oral Iron Therapy

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

PARTICIPATION

Who may participate

Minimum age: 18 Years
Maximum age: 40 Years
Sex eligibility: Female
Healthy volunteers: Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria

Inclusion criteria

* 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
* Known hemoglobinopathies
* Chronic medical illness (renal, hepatic, cardiac)
* Postpartum sepsis or PPH
* Previous iron therapy in current pregnancy

Additional eligibility information

Female with postpartum anemia are included in the study only

NEAR YOU

Study locations worldwide

1 site

Check the individual site’s status and contact the listed study team for current availability.

PAF hospital islamabad

Not reported

Islamabad, Punjab Province, 44100, Pakistan

Contact details are not published in this record. Check official study record ↗

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

INTRAVENOUS FERRIC CARBOXYMALTOSEDrug

Intravenous ferric carboxymaltose is administered as a single dose according to calculated iron deficit within 48hrs after postpartum

Study groups: INTRAVENOUS FERRIC CARBOXYMALTOSE group

oral iron therapyDrug

participants will receive oral ferrous sulphate tablets providing 200mg elemental iron daily till required

Study groups: oral iron therapy group

Study groups

INTRAVENOUS FERRIC CARBOXYMALTOSE groupExperimental

single dose Intravenous ferric carboxymaltose administered postpartum

Interventions: Drug: INTRAVENOUS FERRIC CARBOXYMALTOSE

oral iron therapy groupActive comparator

oral iron therapy to treat anemia as comparative group

Interventions: Drug: oral iron therapy

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomized
Study model: Parallel
Masking: None (open label)
Enrolment: 134 participants · Actual

TIMELINE & MEASURES

Dates and outcomes

Study started: 20 Apr 2026 · Actual
Primary completion: 20 Sep 2026 · Actual
Study completion: 20 Sep 2026 · Actual
First registered: 19 Oct 2026 · Actual
Last registry update: 19 Oct 2026 · Actual
Status last verified: Oct 2026

Primary outcomes (1)

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

Time frame: 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

Time frame: 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. .

Time frame: 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

Time frame: baseline ,2 weeks and 6 weeks postpartum

STUDY TEAM

Sponsor and contacts

Lead sponsor: Pakistan Air Force (PAF) Hospital Islamabad
Sponsor type: Other
Collaborators: Not reported
Organisation study ID: OBGYN -PPA-IRON-MFI-20-2026

Central study contacts

No central contact is currently reported. Check the site contacts or the official record.

Study officials

afia ayyaz, mbbsPrincipal investigator · PAF hospital islamabad

shamsa rizwan, FCPSStudy director · PAF hospital

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Publications (1)

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 ↗