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

Phase 4

• Conditions: Post Partum Hemorrhage; Anemia
• Interventions: Drug: Placebo; Drug: Iron Isomaltoside 1000; Drug: Iberet-Folic-500

• Registration Number: NCT04505514
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Status Verified: 2020-08
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Iron Group	Iberet-Folic-500	-
Oral Iron Group	Placebo	-
Intravenous Iron Group	Iberet-Folic-500	-
Intravenous Iron Group	Iron Isomaltoside 1000	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
Blood transfusion requirement	Up to six weeks after intervention	Number of blood transfusions required after intervention
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.

Trial Locations

Locations (1)

University of Malaya Medical Centre; 🇲🇾 Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia