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

University of Malaya

Status and phase: Unknown; Phase 4

Conditions: Anemia; Post Partum Hemorrhage

Treatments: Drug: Placebo; Drug: Iberet-Folic-500; Drug: Iron Isomaltoside 1000

Study type: Interventional

Funder types: Other

Identifiers

NCT04505514

2020121-8204

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intravenous Iron Group

Experimental group

Treatment:

Drug: Iberet-Folic-500

Drug: Iron Isomaltoside 1000

Oral Iron Group

Active Comparator group

Treatment:

Drug: Iberet-Folic-500

Drug: Placebo