Postpartum HaemorrhagePhase 3PP-01NCT01895218
Treatment of Women After Postpartum Haemorrhage
A Phase 3 study testing Iron isomaltoside 1000 and Standard medical Care in people with Postpartum Haemorrhage, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Haemorrhage
- What is being tested?
- Iron isomaltoside 1000 and Standard medical Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2013to Dec 2014
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
- Willingness to participate and signed the informed consent form
Who cannot join
- Women aged < 18 years
- Multiple births
- Peripartum RBC transfusion
- Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- Women with a history of active asthma within the last 5 years or a history of multiple allergies
Show all 14Show fewer
- Known decompensated liver cirrhosis and active hepatitis
- Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
- Active acute infection assessed by clinical judgement
- Rheumatoid arthritis with symptoms or signs of active joint inflammation
- History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- Not able to read, speak and understand the Danish language
- Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage
The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
- Conditions
- Postpartum Haemorrhage
- Being tested
- Iron isomaltoside 1000, Standard medical Care
- Medical subject headings
- Postpartum Hemorrhage
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®
A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.
Standard medical CareOther
Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside 1000 (Monofer®) | Experimental | Not described Receives: Drug: Iron isomaltoside 1000 |
| Standard medical Care | Active comparator | Not described Receives: Other: Standard medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical fatigue
The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
Measured: From exposure to 12 weeks post-exposure
Secondary outcomes (13)
Change in Hb concentration
Measured: From exposure to week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-ferritin
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in Fatigue symptoms
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in postpartum depression symptoms
Measured: From exposure to 12 weeks post-exposure
Breastfeeding
Measured: From exposure to 12 weeks post-exposure
RCB transfusions
Measured: From exposure to 12 weeks post-exposure
Adverse drug reactions (ADRs)
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-iron
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-transferrin
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of transferrin saturation (TSAT)
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of reticulocyte count
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of mean reticulocyte haemoglobin content (CHr)
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in haematology parameters
Measured: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HaemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895218
- Sponsor's protocol ID
- PP-01
- Acronym
- PP-01
- Status last verified
- Apr 2015
- First submitted
- 26 Jun 2013
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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 29558233Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Jan 14;16:5. doi: 10.1186/1745-6215-16-5.
PubMed 25588587
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A, Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Standard Medical Care in Women After Postpartum Haemorrhage
- ClinicalTrials.gov ID
- NCT01895218
- Acronym / sponsor ID
- PP-01 / PP-01
- Conditions
- Postpartum Haemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jul 2013 (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 primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside 1000 (Monofer®) | Experimental | Drug: Iron isomaltoside 1000 |
| Standard medical Care | Active comparator | Other: Standard medical Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with PPH ≥ 700 and ≤ 1000 mL or PPH > 1000 mL and Hb > 6.5 g/dL (4.0 mmol/L) measured > 12 hours after delivery
- Willingness to participate and signed the informed consent form
Key exclusion criteria (14 listed)
- Women aged < 18 years
- Multiple births
- Peripartum RBC transfusion
- Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
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: Monofer®A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min. | Drug | Iron isomaltoside 1000 (Monofer®) |
| Standard medical CareStandard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day | Other | Standard medical Care |
Primary outcome
Physical fatigue
Time frame: From exposure to 12 weeks post-exposure
The primary objective of this study is to compare efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.
13 secondary outcomes
Change in Hb concentration
Time frame: From exposure to week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-ferritin
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in Fatigue symptoms
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in postpartum depression symptoms
Time frame: From exposure to 12 weeks post-exposure
Breastfeeding
Time frame: From exposure to 12 weeks post-exposure
RCB transfusions
Time frame: From exposure to 12 weeks post-exposure
Adverse drug reactions (ADRs)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-iron
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of p-transferrin
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of transferrin saturation (TSAT)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of reticulocyte count
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in concentrations of mean reticulocyte haemoglobin content (CHr)
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
Change in haematology parameters
Time frame: From exposure to day 3, week 1, 3, 8 and 12 post-exposure
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 29 Apr 2015.
- 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.
- Derived from this study: PubMed 25588587Holm C, Thomsen LL, Norgaard A, Langhoff-Roos J. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Jan 14;16:5. doi: 10.1186/1745-6215-16-5.
Related trials for Postpartum Haemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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 Phase 3 study testing Iron isomaltoside 1000 and Standard medical Care in people with Postpartum Haemorrhage, run by Pharmacosmos A/S at 1 site in Denmark.
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 2 inclusion and 14 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 29 Apr 2015. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical fatigue (time frame: From exposure to 12 weeks post-exposure). 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 NCT01895218, which also lists 2 linked publications.
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 29 Apr 2015.