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Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage

NCT04505514 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-08-12

No results posted yet for this study

Summary

The investigator's study is going to compare effectiveness of single dose intravenous iron in combination with oral iron versus oral iron monotherapy in correcting haemoglobin deficit, replenishing iron stores and improving clinical symptoms in women with post-partum anaemia after postpartum hemorrhage without increasing the rate of adverse outcomes.

Conditions

  • Post Partum Hemorrhage
  • Anemia

Interventions

DRUG

Iron Isomaltoside 1000

single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding

DRUG

Placebo

100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding

DRUG

Iberet-Folic-500

once a day dose, to start 5 days after the intervention

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • Malaysia

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505514 on ClinicalTrials.gov