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

Anemia Clinical Trial

— IVIronPPH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505514
• Other study ID #: 2020121-8204
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: University of Malaya
• Contact: Carolyn Yim Chue Wai, MBBS
• Phone: +603-79493133
• Email: drcarolyim[@]um.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anemia
• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

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
• Placebo
100 ml of 0.9% sodium chloride, infused intravenously over = 20 minutes. - infusion set will be covered for blinding
• Iberet-Folic-500
once a day dose, to start 5 days after the intervention

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Petaling Jaya	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentration (g/dL)	To evaluate the increase in hemoglobin level	Six weeks after intervention
Primary	Serum iron concentration	To evaluate the increase in serum iron concentration (µmol/L)	Six weeks after intervention
Primary	Serum ferritin concentration	serum ferritin levels (µg/L)	six weeks after intervention
Secondary	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
Secondary	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
Secondary	Blood transfusion requirement	Number of blood transfusions required after intervention	Up to six weeks after intervention