Postpartum AnemiaNCT01628770
Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
A study testing Iron isomaltoside 1000 and Ferrous sulphate in people with Postpartum Anemia, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Iron isomaltoside 1000 and Ferrous sulphate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 1 sitePakistan
- Study dates
- May 2012to Dec 2012
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women within 24-48 hours of delivery with hemoglobin concentration < 10gm/dl
Who cannot join
- History of PPH, or significant blood loss in last 24 hours
- History of allergy to iron preparation
- Hemoglobin < 7gm/dl.
- Sign \& symptoms of cardiac failure
- H/o blood transfusion in last 3 months
- H/O Chronic liver diseases.
- ↑ Creatinine > 2mg/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iron Isomaltoside 1000 (Monofer)
The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.
Read the detailed description
Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies
- Conditions
- Postpartum Anemia
- Being tested
- Iron isomaltoside 1000, Ferrous sulphate
- Keywords
- iron, monofer, Pakistan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside 1000Drug
Also called Monofer
Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight.
Ferrous sulphateDrug
200mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| parenteral iron | Experimental | dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion Receives: Drug: Iron isomaltoside 1000 |
| oral iron | Active comparator | oral iron in form of ferrous sulphate 200 mg twice daily Receives: Drug: Ferrous sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see the rise in hemoglobin concentration of 2gm/dl or more.
To see the rise in hemoglobin concentration of 2gm/dl or more.This rise in hemoglobin concentration will be measured at day 14 and at 3 months, in both groups.
Measured: 3 months
Secondary outcomes (1)
secondary - time required for rise in hemoglobin concentration
time required for rise in hemoglobin concentration. Both groups will be compared in terms of time interval, to see the rise in hemoglobin concentration.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum AnemiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Hossain, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628770
- Sponsor's protocol ID
- 7865
- Status last verified
- Aug 2016
- First submitted
- 21 Jun 2012
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.
PubMed 29558233
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Isomaltoside 1000 (Monofer)
- ClinicalTrials.gov ID
- NCT01628770
- Acronym / sponsor ID
- 7865
- Conditions
- Postpartum Anemia
- Keywords
- iron, monofer, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2012 (estimated)
- 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 investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.
Detailed description
Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parenteral iron | Experimental | Drug: Iron isomaltoside 1000dose will be calculated according to Ganzoni's formula, and will be administered by intravenous infusion |
| oral iron | Active comparator | Drug: Ferrous sulphateoral iron in form of ferrous sulphate 200 mg twice daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women within 24-48 hours of delivery with hemoglobin concentration < 10gm/dl
Key exclusion criteria (7 listed)
- History of PPH, or significant blood loss in last 24 hours
- History of allergy to iron preparation
- Hemoglobin < 7gm/dl.
- Sign \& symptoms of cardiac failure
- H/o blood transfusion in last 3 months
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 1000Also: MonoferIron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight. | Drug | parenteral iron |
| Ferrous sulphate200mg twice daily | Drug | oral iron |
Primary outcome
To see the rise in hemoglobin concentration of 2gm/dl or more.
Time frame: 3 months
To see the rise in hemoglobin concentration of 2gm/dl or more.This rise in hemoglobin concentration will be measured at day 14 and at 3 months, in both groups.
1 secondary outcome
secondary - time required for rise in hemoglobin concentration
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Derived from this study: PubMed 29558233Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.
Related trials for Postpartum Anemia
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
RecruitingObservational study
Hemoglobin Testing in Pregnant Patients
Post Partum Hemorrhage, Anemia of Pregnancy
RecruitingPhase 4
Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
Postpartum Depression (PPD)
Not yet recruiting
An RCT Study Between WHO and RCOG Based Practices
Postpartum Anemia
Recruiting
Evaluation of Blood Loss After Cesarean Delivery Via US Compared to Standard Care
Postpartum Period
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron isomaltoside 1000 and Ferrous sulphate in people with Postpartum Anemia, run by Dow University of Health Sciences at 1 site in Pakistan.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 3 Aug 2016. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To see the rise in hemoglobin concentration of 2gm/dl or more. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01628770, which also lists 1 linked publication.
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 3 Aug 2016.