Postoperative AnaemiaPhase 4VITAPOPNCT01975272
The Use of Iron Therapy for Patients With Anemia After Caesarean Section
A Phase 4 study testing Ferinject and Ferrous fumarate in people with Postoperative Anaemia, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Anaemia
- What is being tested?
- Ferinject and Ferrous fumarate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 2 sitesNetherlands
- Study dates
- 2 Mar 2015to 21 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gynecological surgery
- Hb 5-7 mmol/L
Who cannot join
- Pregnancy
- Oncological operations
- Infections (PID)
- Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
- Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
- Small vulvar / vaginal operations such as (cysts, labia correction)
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- Endometrial ablation
- Legal incapacity
- The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
- Hematologic disorders
- Erythropoiesis-stimulating agents \< 3months ago
- Myelosuppressive therapy in history
- Hepatitis
- HIV
- Alcohol abuses
- Not understanding Dutch
- Allergic reaction to iron therapy in past
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
Orbis Medical Centre
Sittard, Limburg, 6162 BG
About this study
Official title: The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.
Read the detailed description
Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.
The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.
- Conditions
- Postoperative Anaemia
- Being tested
- Ferinject, Ferrous fumarate, Placebo for ferrous fumarate, Placebo for ferinject
- Keywords
- postoperative, anemia, gynaecologic, surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called intravenous iron, ferric carboxymaltose
Ferrous fumarateDrug
Also called Oral iron, Iron (II) fumarate
Placebo for ferrous fumarateDrug
Also called Placebo tablets
Placebo for ferinjectDrug
Also called NaCl
| Study group | Role | What they receive |
|---|---|---|
| Ferinject | Active comparator | Once an infusion of Ferinject 1000 mg, 1 day after surgery Receives: Drug: Ferinject; Drug: Placebo for ferrous fumarate |
| Ferrous fumarate | Active comparator | 2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery Receives: Drug: Ferrous fumarate; Drug: Placebo for ferinject |
| Placebo infusion and tablets | Placebo comparator | Patient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery Receives: Drug: Placebo for ferrous fumarate; Drug: Placebo for ferinject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Serum hemoglobin level
Measured: 3 weeks postoperative
Secondary outcomes (2)
Serum Ferritin
Serum levels of ferritin
Measured: 3 weeks postoperative
Serum Hepcidin
Serum hepcidin level
Measured: 3 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study start2 Mar 2015
- Primary completion17 May 2018
- Study completion21 Jun 2018
Why it stopped: Disapointing randomization rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative AnaemiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Roy Kruitwagen, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975272
- Sponsor's protocol ID
- METC 12-2-018
- Acronym
- VITAPOP
- Status last verified
- Mar 2022
- First submitted
- 30 Sep 2013
- Last updated
- 22 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01975272
- Acronym / sponsor ID
- VITAPOP / METC 12-2-018
- Conditions
- Postoperative Anaemia
- Keywords
- postoperative, anemia, gynaecologic, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Disapointing randomization rate
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Posted 22 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.
Detailed description
Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.
The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferinject | Active comparator | Drug: Ferinject, Drug: Placebo for ferrous fumarateOnce an infusion of Ferinject 1000 mg, 1 day after surgery |
| Ferrous fumarate | Active comparator | Drug: Ferrous fumarate, Drug: Placebo for ferinject2 times a day 200 mg ferrous fumarate, starting 24-48 hours after surgery |
| Placebo infusion and tablets | Placebo comparator | Drug: Placebo for ferrous fumarate, Drug: Placebo for ferinjectPatient will get a once a placebo infusion (250 ml NaCl), one day after surgery, and 60 placebo tablets for 30 days (2 tablets a day), starting 24-48 hours after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gynecological surgery
- Hb 5-7 mmol/L
Key exclusion criteria (17 listed)
- Pregnancy
- Oncological operations
- Infections (PID)
- Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
- Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
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 |
|---|---|---|
| FerinjectAlso: intravenous iron, ferric carboxymaltose | Drug | Ferinject |
| Ferrous fumarateAlso: Oral iron, Iron (II) fumarate | Drug | Ferrous fumarate |
| Placebo for ferrous fumarateAlso: Placebo tablets | Drug | Ferinject, Placebo infusion and tablets |
| Placebo for ferinjectAlso: NaCl | Drug | Ferrous fumarate, Placebo infusion and tablets |
Primary outcome
Hemoglobin
Time frame: 3 weeks postoperative
Serum hemoglobin level
2 secondary outcomes
Serum Ferritin
Time frame: 3 weeks postoperative
Serum Hepcidin
Time frame: 3 weeks postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roy Kruitwagen principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Ferrous fumarate in people with Postoperative Anaemia, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 17 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: stopped early, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin (time frame: 3 weeks postoperative). 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 22 Aug 2022.