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PregnancyNCT02441439

To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

A study testing Iron sucrose 200 mg and Iron sucrose 500 mg in people with Pregnancy, run by HaEmek Medical Center, Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy
What is being tested?
Iron sucrose 200 mg and Iron sucrose 500 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 7 Nov 2022
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

  • Singleton pregnancy
  • Iron deficiency anemia
  • Intolerance or low compliance for oral iron

Who cannot join

  • Known allergy for iron supplements
  • Anemia not due to iron deficiency
  • Acute infection
  • Liver failure or viral hepatitis
  • Thalassemia or hemoglobinopathies
  • Asthma
  • Multiple pregnancy

About this study

This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

Read the detailed description

Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.

Conditions
Pregnancy
Being tested
Iron sucrose 200 mg, Iron sucrose 500 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iron sucrose 200 mgDietary supplement

    I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes

  • Iron sucrose 500 mgDietary supplement

    I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours

Study groups in NCT02441439
Study groupRoleWhat they receive
Iron sucrose 200 mgOtherfirst arm will be treated with iron sucrose 200 mg 2-3 times a week
Receives: Dietary Supplement: Iron sucrose 200 mg
Iron sucrose 500 mgActive comparatorSecond arm will be treated with iron sucrose 500 mg once a week
Receives: Dietary Supplement: Iron sucrose 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change between the hemoglobin level at randomization and the hemoglobin level at the time of delivery

    Hemoglobin levels will be obtained at the beginning of the study and around delivery

    Measured: from randomization to delivery

  2. Women's satisfaction from the protocol treatment according to the VAS (visual analog scale)

    Measured: The day after delivery

Secondary outcomes (9)

  1. Type and rate of adverse events

    Measured: Up to 30 weeks

  2. The rate of patients who discontinued treatment

    Measured: Up to 30 weeks

  3. The weekly change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from randomization

    Measured: Up to 4 weeks

  4. The change in hemoglobin level, ferritin, serum iron, transferrin, MCV, iron saturation and reticolocyte count from the last dose of iron sucrose to delivery in 3 weeks intervals

    Measured: Up to 30 weeks

  5. The need for blood transfusion post partum

    Measured: up to 4 days post partum

  6. The need for iron sucrose administration post partum

    Measured: up to 4 days post partum

  7. The rate of anemia associated symptoms

    Measured: From randomization and up to 30 weeks

  8. The levels of neonatal hemoglobin, ferritin and bilirubin

    Measured: up to 4 days post partum

  9. The rate of neonatal polycythemia and need for phototherapy

    Measured: up to 4 days post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study start1 Jan 2022
  3. Primary completion7 Nov 2022
  4. Study completion7 Nov 2022

Why it stopped: The investigators decided not to proceed with this study

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02441439
Sponsor's protocol ID
0036-15
Status last verified
Nov 2022
First submitted
6 May 2015
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Iron sucrose 200 mg and Iron sucrose 500 mg in people with Pregnancy, run by HaEmek Medical Center, 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 3 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: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 at the time of delivery (time frame: from randomization to delivery). The study lists 2 primary outcomes in all. 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 NCT02441439.

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 8 Nov 2022.

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