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

NCT03957057 | Completed Phase 3

• 1 other identifier: 0120-117/2019/5
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Anemia Nos; Iron-deficiency

Keywords

postpartum anemia; iron deficiency; ferrous sulphate; ferric carboxymaltose; ferric isomaltoside

Outcome Measures

Primary Outcomes (1)

• Multidimensional Fatigue Inventory (MFI) score

  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.

  6 weeks postpartum

Secondary Outcomes (10)

• Edinburgh Postnatal Depression Scale (EPDS) score

  6 weeks postpartum

• hemoglobin

  6 weeks postpartum

• hemoglobin level > 120 g/L

  6 weeks postpartum

• ferritin level > 50 mcg/L at 6 weeks postpartum

  6 weeks postpartum

• reticulocyte count

  6 weeks postpartum

Study Arms (3)

Iron carboxymaltose group

EXPERIMENTAL

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

Iron isomaltoside group

EXPERIMENTAL

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

Iron sulphate group

ACTIVE COMPARATOR

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

Interventions

Iron Carboxymaltose DRUG

Intravenous iron carboxymaltose application

Iron carboxymaltose group

Iron Isomaltoside DRUG

Inravenous iron isomaltoside application

Iron isomaltoside group

Ferrous sulphate DRUG

Oral ferrous sulphate application

Iron sulphate group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pospartum women will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric carboxymaltose; iron isomaltoside 1000; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Miha Lucovnik, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 21, 2019
• Study Start: September 10, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 15, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

SL (1)