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Intravenous Iron Carboxymaltose, Isomaltoside and Oral Iron Sulphate for Postpartum Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957057
Recruitment Status : Suspended (Covid-19)
First Posted : May 21, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Miha Lucovnik, University Medical Centre Ljubljana

Brief Summary:

Anemia affects between 20 and 50 % of women in the postpartum period. It is associated with several adverse health consequences, such as impaired physical work capacity, deficits in cognitive function and mood, reduced immune function and reduced duration of breastfeeding. Postpartum anemia has also been shown to be a major risk factor for postpartum depression and to significantly disrupt maternal-infant interactions. Iron deficiency is the principal cause of anemia after delivery. Oral iron supplementation with ferrous sulfate has been considered the standard of care with blood transfusion reserved for more severe or symptomatic cases. In the last decade, two new intravenous iron compounds have been registered for clinical use: ferric carboxymaltose (Iroprem®) and iron isomaltoside (Monofer®). No study to date compared efficacy of iron carboxymaltose to iron isomaltoside for treatment of postpartum anemia.

The objective of the study is to compare efficacy of intravenous iron carboxymaltose to intravenous iron isomaltoside and oral iron sulphate for treatment of postpartum anemia.


Condition or disease Intervention/treatment Phase
Postpartum Anemia Nos Iron-deficiency Drug: Iron Carboxymaltose Drug: Iron Isomaltoside Drug: Ferrous sulphate Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Intravenous Iron Carboxymaltose, Intravenous Iron Isomaltoside and Oral Iron Sulphate for Postpartum Anemia
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : July 15, 2021


Arm Intervention/treatment
Experimental: Iron carboxymaltose group
Iron carboxymaltose group. Total dose of intravenous ferric carboxymaltose (Iroprem®) needed to correct anemia and replenish iron stores will be calculated using the Ganzoni formula (28) modified to include adjustment for baseline iron status: prepregnancy weight in kilograms X (15-baseline Hb) X 2.4 + 500. Fifteen is the target Hb in g/dL, 2.4 is a unit less conversion constant and 500 is the target iron stores in mg. The maximal dose administered in a single day will not exceed 15 mg/kg (current weight) or 1000 mg (for participants with body weight > 67 kg). If total calculated dose will exceed 15 mg/kg or 1000 mg, subsequent doses will be administered weekly until the total calculated dose will be reached.
Drug: Iron Carboxymaltose
Intravenous iron carboxymaltose application

Experimental: Iron isomaltoside group
Total dose of intravenous iron isomaltoside (Monofer®) needed to correct anemia and replenish iron stores will be calculated as described above. The maximal dose administered in a single day will not exceed 20 mg/kg (current weight) or 1500 mg (for participants with body weight > 75 kg). If total calculated dose will exceed 20 mg/kg or 1500 mg, subsequent doses will be administered weekly until the total calculated dose will be reached.
Drug: Iron Isomaltoside
Inravenous iron isomaltoside application

Active Comparator: Iron sulphate group
Iron sulphate group. Participants will receive oral ferrous sulphate (Tardyfer®) 160 mg daily for 6 weeks with instruction to take two tablets by mouth once daily 1 hour before meal. They will receive no additional iron supplementation.
Drug: Ferrous sulphate
Oral ferrous sulphate application




Primary Outcome Measures :
  1. Multidimensional Fatigue Inventory (MFI) score [ Time Frame: 6 weeks postpartum ]
    Multidimensional Fatigue Inventory (MFI) score at 6 weeks postpartum. The MFI is a 20-item self-report instrument designed to measure fatigue. Items are scored 1-5, with 10 positively phrased items reverse scored (this concerns following items: 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). For each of the 5 scales (general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue) a total score is calculated by summation of the scores of the individual items. Scores can range from the minimum of 4 to the maximum of 20. Higher scores indicate a higher degree of fatigue.


Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) score [ Time Frame: 6 weeks postpartum ]
    Edinburgh Postnatal Depression Scale (EPDS) score at 6 weeks postpartum. EPDA is a 10-item questionnaire which evaluates different depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Each answer is given a score of 0 to 3 . The maximum score is 30. Higher scores indicate more depressive symptoms. A score of more than 10 suggests minor or major depression may be present.

  2. hemoglobin [ Time Frame: 6 weeks postpartum ]
    Mean hemoglobin level at 6 weeks postpartum

  3. hemoglobin level > 120 g/L [ Time Frame: 6 weeks postpartum ]
    Proportion of participants with hemoglobin level > 120 g/L at 6 weeks postpartum

  4. ferritin level > 50 mcg/L at 6 weeks postpartum [ Time Frame: 6 weeks postpartum ]
    Proportion of participants with ferritin level > 50 mcg/L

  5. reticulocyte count [ Time Frame: 6 weeks postpartum ]
    Mean reticulocyte count

  6. ferritin level [ Time Frame: 6 weeks postpartum ]
    Mean ferritin level

  7. transferrin level [ Time Frame: 6 weeks postpartum ]
    Mean transferrin level

  8. Costs of medication used in each study arm [ Time Frame: 6 weeks postpartum ]
    Costs of treatments

  9. Compliance - proportion of participants receiving treatments as recommended [ Time Frame: 6 weeks postpartum ]
    Compliance with oral ferrous sulphate treatment

  10. Side effects - proportion of participants reporting side effects of treatments [ Time Frame: 6 weeks postpartum ]
    Side effects of all three study treatments in mothers (e.g. constipation, headache, infusion site burning) and infants (e.g. constipation, erythema, diarrhea, abdominal pain, upper respiratory tract infection)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pospartum women will be included in the study.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postpartum patients with a hemoglobin level between 70 g/L and 100 g/L within 48 hours after delivery.

Exclusion Criteria:

  • Contraindications for any of the study drugs.
  • Anemia due to causes other than iron deficiency.
  • Signs of systemic infection.
  • Renal or hepatic dysfunction.
  • Depression during pregnancy or pre-existing depressive disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957057


Locations
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Slovenia
UMC Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Miha Lucovnik, MD, PhD UMC Ljubljana
  Study Documents (Full-Text)

Documents provided by Miha Lucovnik, University Medical Centre Ljubljana:
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Responsible Party: Miha Lucovnik, assistant professor, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03957057    
Other Study ID Numbers: 0120-117/2019/5
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators will be willing to share IPD after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Miha Lucovnik, University Medical Centre Ljubljana:
postpartum anemia
iron deficiency
ferrous sulphate
ferric carboxymaltose
ferric isomaltoside
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs