Postpartum Fatigue, Iron Deficiency Anemia
Conditions
Keywords
postpartum anemia, postpartum fatigue, iron deficiency anemia
Brief 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 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
Interventions
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
Sponsors
Pakistan Air Force (PAF) Hospital Islamabad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in Maternal fatigue total score on the Multidimensional fatigue inventory | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in breastfeeding self efficacy scale short form score | baseline 2 week and 6 week postpartum | 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 |
| number of participants with treatment emergent adverse effects | 2 week and 6 week posttreatment | 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. . |
| change from baseline in depressive symptoms on the Edinberg postnatal depression scale | baseline ,2 weeks and 6 weeks postpartum | 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 |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORafia ayyaz, mbbs
PAF hospital islamabad
STUDY_DIRECTORshamsa rizwan, FCPS
PAF hospital
Outcome results
None listed