Post Partum HemorrhagePhase 4IVIronPPHNCT04505514
Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage
A Phase 4 study testing Iron Isomaltoside 1000 and Iberet-Folic-500 in people with Post Partum Hemorrhage and Anemia, run by University of Malaya at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post Partum Hemorrhage, Anemia
- What is being tested?
- Iron Isomaltoside 1000 and Iberet-Folic-500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2020to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 59100
Carolyn Yim Chue Wai, MBBS, +603-79493133, drcarolyim@um.edu.my
About this study
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
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
- Being tested
- Iron Isomaltoside 1000, Placebo, Iberet-Folic-500
- Medical subject headings
- Postpartum Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
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
PlaceboDrug
100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
- infusion set will be covered for blinding
Iberet-Folic-500Drug
once a day dose, to start 5 days after the intervention
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Iron Group | Experimental | Not described Receives: Drug: Iron Isomaltoside 1000; Drug: Iberet-Folic-500 |
| Oral Iron Group | Active comparator | Not described Receives: Drug: Placebo; Drug: Iberet-Folic-500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration (g/dL)
To evaluate the increase in hemoglobin level
Measured: Six weeks after intervention
Serum iron concentration
To evaluate the increase in serum iron concentration (µmol/L)
Measured: Six weeks after intervention
Serum ferritin concentration
serum ferritin levels (µg/L)
Measured: six weeks after intervention
Secondary outcomes (3)
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.
Measured: Six weeks after intervention
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.
Measured: Up to six weeks after intervention
Blood transfusion requirement
Number of blood transfusions required after intervention
Measured: Up to six weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Carolyn Yim Chue Wai, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505514
- Sponsor's protocol ID
- 2020121-8204
- Acronym
- IVIronPPH
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04505514
- Acronym / sponsor ID
- IVIronPPH / 2020121-8204
- Conditions
- Post Partum Hemorrhage, Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Iron Group | Experimental | Drug: Iron Isomaltoside 1000, Drug: Iberet-Folic-500 |
| Oral Iron Group | Active comparator | Drug: Placebo, Drug: Iberet-Folic-500 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Isomaltoside 1000single 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 | Intravenous Iron Group |
| Placebo100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes. - infusion set will be covered for blinding | Drug | Oral Iron Group |
| Iberet-Folic-500once a day dose, to start 5 days after the intervention | Drug | Intravenous Iron Group, Oral Iron Group |
Primary outcome
Hemoglobin concentration (g/dL)
Time frame: Six weeks after intervention
To evaluate the increase in hemoglobin level
Serum iron concentration
Time frame: Six weeks after intervention
To evaluate the increase in serum iron concentration (µmol/L)
Serum ferritin concentration
Time frame: six weeks after intervention
serum ferritin levels (µg/L)
3 secondary outcomes
General fatigue score
Time frame: Six weeks after intervention
Number of participants that had adverse effects to intravenous iron
Time frame: Up to six weeks after intervention
Blood transfusion requirement
Time frame: Up to six weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Isomaltoside 1000 and Iberet-Folic-500 in people with Post Partum Hemorrhage and Anemia, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Yim Chue Wai, MBBS (+603-79493133, drcarolyim@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration (g/dL) (time frame: Six weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.