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

NCT04505514 | Unknown Phase 4

• 1 other identifier: 2020121-8204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Hemorrhage; Anemia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• General fatigue score

  Six weeks after intervention

• Number of participants that had adverse effects to intravenous iron

  Up to six weeks after intervention

• Blood transfusion requirement

  Up to six weeks after intervention

Study Arms (2)

Intravenous Iron Group

EXPERIMENTAL

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

Oral Iron Group

ACTIVE COMPARATOR

Drug: Placebo; Drug: Iberet-Folic-500

Interventions

Iron Isomaltoside 1000 DRUG

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

Intravenous Iron Group

Placebo DRUG

100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. \- infusion set will be covered for blinding

Oral Iron Group

Iberet-Folic-500 DRUG

once a day dose, to start 5 days after the intervention

Intravenous Iron Group; Oral Iron Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Anemia

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Carolyn Yim Chue Wai, MBBS

CONTACT

+603-79493133; drcarolyim@um.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

MY (1)