Postpartum AnemiaNCT02458625
A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia
A study testing Iron sucrose 500 mg and Iron bisglycinate 60 mg in people with Postpartum Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Anemia
- What is being tested?
- Iron sucrose 500 mg and Iron bisglycinate 60 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to 4 Nov 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women above 18 years old after giving birth
- Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the exclusion criteria
Who cannot join
- Women who suffer from known allergy for iron supplements
- Women who suffer from anemia not due to iron deficiency
- Women who suffer from acute infection
- Women who suffer from liver failure or viral hepatitis
- Women who suffer from thalassemia or hemoglobinopathies
- Women who suffer from renal failure
- Women who suffer from unbalanced thyroid disorder
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Read the detailed description
Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
- Conditions
- Postpartum Anemia
- Being tested
- Iron sucrose 500 mg, Iron bisglycinate 60 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron sucrose 500 mgDietary supplement
Iron bisglycinate 60 mgDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Iron sucrose 500 mg | Active comparator | One treatment arm will receive a single dose of I.V iron sucrose 500 mg. Receives: Dietary Supplement: Iron sucrose 500 mg |
| Iron sucrose 500 mg+60 mg Iron bisglycinate | Active comparator | Second treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth. Receives: Dietary Supplement: Iron sucrose 500 mg; Dietary Supplement: Iron bisglycinate 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
Measured: After 6 weeks post partum
Secondary outcomes (6)
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum
Measured: Up to 6 weeks post partum
The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire
Measured: six weeks post partum
Type and rate of adverse events
Measured: Up to 6 weeks post partum
The rate of patients who discontinued treatment
Measured: Up to 6 weeks post partum
The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum
Measured: From randomization to 6 weeks post partum
The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment
Measured: Six weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startApr 2016
- Primary completion7 Jun 2020
- Study completion4 Nov 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohar Nachum, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458625
- Sponsor's protocol ID
- 0133-14
- Status last verified
- Nov 2020
- First submitted
- 28 May 2015
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23.
PubMed 34171389
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia
- ClinicalTrials.gov ID
- NCT02458625
- Acronym / sponsor ID
- 0133-14
- Conditions
- Postpartum Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 7 Jun 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 1 Jun 2015 (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.
This study is aimed to compare the efficacy of two mode of iron administration to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Detailed description
Anemia is common following delivery. It is associated with disturbing symptoms such as fatigue, cognitive impairment and syncope in severe cases. International guidelines recommend to use intravenous iron sucrose to treat intermediate and severe anemia until the target hemoglobin is achieved. However, patient's compliance after delivery is low, making the administration of several doses difficult. In those cases oral iron supplements might be used. In the present study the investigators will compare the efficacy of two iron administration protocols to treat post partum anemia - a single dose of intravenous iron sucrose versus a single dose of iron sucrose and 6 weeks of treatment with oral iron supplement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron sucrose 500 mg | Active comparator | Dietary Supplement: Iron sucrose 500 mgOne treatment arm will receive a single dose of I.V iron sucrose 500 mg. |
| Iron sucrose 500 mg+60 mg Iron bisglycinate | Active comparator | Dietary Supplement: Iron sucrose 500 mg, Dietary Supplement: Iron bisglycinate 60 mgSecond treatment arm will receive a single dose of I.V iron sucrose 500 mg and oral treatment with 60 mg Iron bisglycinate for 6 weeks after giving birth. |
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 above 18 years old after giving birth
- Women who suffer from iron deficiency anemia, defined as hemoglobin< 9.5 g/dl without one of the conditions that are described in the exclusion criteria
Key exclusion criteria (7 listed)
- Women who suffer from known allergy for iron supplements
- Women who suffer from anemia not due to iron deficiency
- Women who suffer from acute infection
- Women who suffer from liver failure or viral hepatitis
- Women who suffer from thalassemia or hemoglobinopathies
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 sucrose 500 mg | Dietary supplement | Iron sucrose 500 mg, Iron sucrose 500 mg+60 mg Iron bisglycinate |
| Iron bisglycinate 60 mg | Dietary supplement | Iron sucrose 500 mg+60 mg Iron bisglycinate |
Primary outcome
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum
Time frame: After 6 weeks post partum
6 secondary outcomes
Women's satisfaction from the protocol treatment according to the VAS (visual analog scale) after 6 weeks post partum
Time frame: Up to 6 weeks post partum
The composite symptoms of anemia and functional capacity after 6 weeks postpartum as assessed by a questionnaire
Time frame: six weeks post partum
Type and rate of adverse events
Time frame: Up to 6 weeks post partum
The rate of patients who discontinued treatment
Time frame: Up to 6 weeks post partum
The change in hemoglobin level, ferritin, serum iron, transferrin, MCV and iron saturation from randomization to 6 weeks post partum
Time frame: From randomization to 6 weeks post partum
The rate of women who will reach a target hemoglobin of at least 12 g/dl after 6 weeks of treatment
Time frame: Six weeks post partum
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 6 Nov 2020.
- Derived from this study: PubMed 34171389Yefet E, Mruat Rabah S, Sela ND, Hosary Mhamed S, Yossef A, Nachum Z. Addition of oral iron bisglycinate to intravenous iron sucrose for the treatment of postpartum anemia-randomized controlled trial. Am J Obstet Gynecol. 2021 Dec;225(6):668.e1-668.e9. doi: 10.1016/j.ajog.2021.06.069. Epub 2021 Jun 23.
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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.
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 sucrose 500 mg and Iron bisglycinate 60 mg in people with Postpartum Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 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 6 Nov 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 Israel. 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?
The change between the hemoglobin level at randomization and the hemoglobin level after 6 weeks postpartum (time frame: After 6 weeks post partum). 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 NCT02458625, 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 6 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.