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

• Sponsor: University of Malaya (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04505514
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Partum Hemorrhage; Anemia	Drug: Iron Isomaltoside 1000; Drug: Placebo; Drug: Iberet-Folic-500	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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: 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

Outcome Measures

Primary Outcome Measures

1. Hemoglobin concentration (g/dL) [Six weeks after intervention]

   To evaluate the increase in hemoglobin level

2. Serum iron concentration [Six weeks after intervention]

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

3. Serum ferritin concentration [six weeks after intervention]

   serum ferritin levels (µg/L)

Secondary Outcome Measures

1. General fatigue score [Six weeks after intervention]

   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.

2. Number of participants that had adverse effects to intravenous iron [Up to six weeks after intervention]

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

3. Blood transfusion requirement [Up to six weeks after intervention]

   Number of blood transfusions required after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: 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:

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya Medical Centre	Petaling Jaya	Wilayah Persekutuan Kuala Lumpur	Malaysia	59100

Sponsors and Collaborators

• University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Carolyn Yim Chue Wai, Consultant Anaesthesiologist, University of Malaya
• ClinicalTrials.gov Identifier: NCT04505514
• Other Study ID Numbers: 2020121-8204
• First Posted: Aug 10, 2020
• Last Update Posted: Aug 12, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Postpartum Hemorrhage; Anemia; Hemorrhage; Iron isomaltoside 1000

Study Results

No Results Posted as of Aug 12, 2020