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

Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage: A Single-blinded, Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Post Partum Hemorrhage
• Intervention / Treatment: Drug: Iron Isomaltoside 1000; Drug: Iberet-Folic-500; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carolyn Yim Chue Wai, MBBS; Phone Number: +603-79493133; Email: drcarolyim@um.edu.my

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
      • Recruiting
      • University of Malaya Medical Centre
      • Contact: Carolyn Yim Chue Wai, MBBS; Phone Number: +603-79493133; Email: drcarolyim@um.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Iron Group	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: Iberet-Folic-500; once a day dose, to start 5 days after the intervention
Active Comparator: Oral Iron Group	Drug: Iberet-Folic-500; once a day dose, to start 5 days after the intervention; Drug: Placebo; 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. - infusion set will be covered for blinding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin concentration (g/dL)	To evaluate the increase in hemoglobin level	Six weeks after intervention
Serum iron concentration	To evaluate the increase in serum iron concentration (µmol/L)	Six weeks after intervention
Serum ferritin concentration	serum ferritin levels (µg/L)	six weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Six weeks after intervention
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.	Up to six weeks after intervention
Blood transfusion requirement	Number of blood transfusions required after intervention	Up to six weeks after intervention

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Anemia; Postpartum Hemorrhage; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: 2020121-8204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No