A Phase 4 interventional study of INTRAVENOUS FERRIC CARBOXYMALTOSE and oral iron therapy in Postpartum Fatigue and Iron Deficiency Anemia, sponsored by Pakistan Air Force (PAF) Hospital Islamabad. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Pakistan Air Force (PAF) Hospital Islamabad · Phase 4, Interventional, and Health services research
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 .
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
660 studies on the registry are indexed under Anemia, Iron-Deficiency; 106 are open to participants now.
This study's enrollment of 134 is above the median of 100 across 515 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Pakistan Air Force (PAF) Hospital Islamabad is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
single dose Intravenous ferric carboxymaltose administered postpartum
Drug: INTRAVENOUS FERRIC CARBOXYMALTOSE
oral iron therapy to treat anemia as comparative group
Drug: oral iron therapy
Intravenous ferric carboxymaltose is administered as a single dose according to calculated iron deficit within 48hrs after postpartum
participants will receive oral ferrous sulphate tablets providing 200mg elemental iron daily till required
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
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
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric carboxymaltose
Pakistan Air Force (PAF) Hospital Islamabad