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Status unknownNCT04505514IVIronPPHUpdated Aug 12, 2020

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

A Phase 4 interventional study of Iron Isomaltoside 1000 and Placebo in Post Partum Hemorrhage and Anemia, sponsored by University of Malaya. Status unknown at 1 site in Malaysia. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by University of Malaya · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

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.

02

Conditions studied

  • Post Partum Hemorrhage
  • Anemia
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's planned enrollment of 60 is below the median of 148 across 340 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • women who underwent spontaneous vaginal delivery with Post partum hemorrhage (PPH) ≥ 500ml OR women who underwent lower segment caesarean section with PPH ≥ 1000 ml
  • post PPH haemoglobin level ≤ 10.0 g/dl measured within 48hrs after delivery and stabilisation \& resuscitation.
  • ≥ 18 years of age
  • Proficient in Malaysian language or English language
  • Willingness to consent for blood taking and attending follow-up at 2 weeks and 6 weeks

Exclusion criteria

Exclusion Criteria:

  • refused consent to participate in trial
  • history of hemolytic anemia, Thalassemia , and sickle cell anemia
  • women with signs of sepsis (clinical or laboratory evidence-intrapartum fever >38.5 degrees with abnormal vital signs, positive blood culture)
  • clinical or laboratory evidence of hepatic or renal, cardiovascular and hemolytic abnormalities
  • history of active severe acid peptic disorder, esophagitis or hiatus hernia and malabsorption syndrome.
  • Severe symptoms of anemia including dyspnoea at rest, angina pectoris, syncope or transient ischemic attacks.
  • history of severe asthma, eczema or other atopic allergy
  • known allergy to iron
  • patients with known immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intravenous Iron Group

    Drug: Iron Isomaltoside 1000 · Drug: Iberet-Folic-500

  • Active comparator
    Oral Iron Group

    Drug: Placebo · Drug: Iberet-Folic-500

Interventions

  • DrugIron 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

  • DrugPlacebo

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

  • DrugIberet-Folic-500

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

06

What researchers measure

Primary outcomes

  1. Hemoglobin concentration (g/dL)

    To evaluate the increase in hemoglobin level

    Time frame: Six weeks after intervention

  2. Serum iron concentration

    To evaluate the increase in serum iron concentration (µmol/L)

    Time frame: Six weeks after intervention

  3. Serum ferritin concentration

    serum ferritin levels (µg/L)

    Time frame: six weeks after intervention

Secondary outcomes

  1. General fatigue score

    Using the Multidimensional Fatigue Inventory (MFI) which will be answered by the participants, scores will be taken ranging from lowest 4, till the highest of 20. A higher score will indicate higher levels of fatigue.

    Time frame: Six weeks after intervention

  2. Number of participants that had adverse effects to intravenous iron

    Any adverse effects experienced by the participant arising from the administration of intravenous iron isomaltoside will be documented and managed as per protocol.

    Time frame: Up to six weeks after intervention

  3. Blood transfusion requirement

    Number of blood transfusions required after intervention

    Time frame: Up to six weeks after intervention

07

Study locations

1 of 1 sites recruiting
  • University of Malaya Medical Centre
    Petaling Jaya, Wilayah Persekutuan Kuala Lumpur 59100, Malaysia
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04505514
Lead sponsor
University of Malaya
Responsible party
Dr Carolyn Yim Chue Wai (Consultant Anaesthesiologist, University of Malaya) — Principal investigator
First posted
Aug 10, 2020
Start date
Aug 1, 2020
Primary completion
Oct 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 12, 2020

Study contacts

Carolyn Yim Chue Wai, MBBS
Contact
drcarolyim@um.edu.my
+603-79493133

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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