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Study on Treating Anemia After Cesarean with Ferric Carboxymaltose or Oral Iron in Women with Moderate Iron Deficiency Anemia

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of anemia in women who have undergone a caesarean delivery. Anemia is a condition where there is a lower than normal number of red blood cells, which can lead to fatigue and weakness. The study will compare the effects of two types of iron treatments: intravenous (IV) iron and oral iron. The IV iron used in this study is called Ferinject, which contains ferric carboxymaltose. The oral iron treatments include Timoferol in two forms: a coated tablet containing dried ferrous sulfate and a hard capsule containing both ascorbic acid and ferrous sulfate.

The purpose of the study is to assess how these treatments affect the prevalence of postpartum depression at 8 weeks after delivery in women with moderate iron deficiency anemia following a caesarean section. Postpartum depression is a type of depression that can occur after childbirth, affecting a mother's mood and overall well-being. The study will involve monitoring the participants over a period of 8 weeks to observe any changes in their condition and to evaluate the effectiveness of the treatments.

Participants will receive either the IV iron or one of the oral iron treatments, or a placebo, and their health will be monitored throughout the study. The study aims to provide valuable insights into the best treatment options for managing anemia and reducing the risk of postpartum depression in new mothers. The findings could help improve care for women experiencing these conditions after a caesarean delivery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed by signing an informed consent form. Eligibility is based on specific criteria, including age, delivery method, and health status after delivery.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm moderate iron deficiency anemia. This involves measuring hemoglobin levels and other blood parameters within 72 hours after delivery.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to receive either oral or intravenous iron treatment. The oral treatment involves taking TIMOFEROL tablets or capsules, while the intravenous treatment involves receiving Ferinject injections.

  4. Step 4

    Treatment administration

    For oral treatment, TIMOFEROL is administered as a coated tablet or hard capsule. The dosage and frequency are determined by the study protocol.

    For intravenous treatment, Ferinject is administered as a dispersion for injection or infusion. The dosage and frequency are determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for any side effects or reactions to the treatment. This includes checking for immune reactions and gastrointestinal side effects.

    Regular follow-up assessments are conducted to measure hemoglobin levels, ferritin levels, and other health indicators.

  6. Step 6

    Evaluation of outcomes

    At 8 weeks postpartum, the primary outcome is assessed by evaluating symptoms of postpartum depression using the Edinburgh Postpartum Depression Scale (EPDS).

    Secondary outcomes include changes in hemoglobin levels, ferritin levels, and fatigue scores, as well as the need for additional medical interventions.

  7. Step 7

    Long-term follow-up

    At 6 months postpartum, long-term outcomes are evaluated, including the occurrence of postpartum depression and changes in fatigue scores.

    The bond between mother and child is also assessed during this period.

Who can join the trial?

9 criteria

  • Must be a woman who has given birth by **caesarean delivery**. This means the baby was delivered through a surgical procedure.
  • Must be at least **18 years old**.
  • Must have been pregnant for at least **32 weeks** before delivery.
  • Must have a **postoperative Hb level** (a measure of hemoglobin in the blood) between **8.0 g/dL and 10.0 g/dL** within 72 hours after delivery.
  • Must have signed an **informed consent form**, which means agreeing to participate in the study after understanding what it involves.
  • Must be **hospitalized in the postpartum maternity ward**, which is the area of the hospital where new mothers stay after giving birth.
  • Must have **national social security coverage**, including AME, which is a type of health coverage.
  • Must have a **ferritinemia** (a measure of iron storage in the body) of **100 ng/mL or less** OR a **transferrin saturation** (a measure of how much iron is being carried in the blood) of **20% or less**.
  • Must have an **EPDS score** (a measure of mood) of less than **11** in the immediate postpartum period, with a "never" answer to question number 10.

Who cannot join the trial?

5 criteria

  • Women who have not delivered by caesarean section.
  • Women who do not have moderate postpartum iron deficiency anemia. This means their blood levels are not between 8.0 and 10.0 grams per deciliter (g/dL) within 72 hours after delivery, or their iron storage levels (ferritin) are not 100 nanograms per milliliter (ng/mL) or less, or their transferrin saturation is not 20% or less. Transferrin saturation is a measure of how much iron is being carried in the blood.
  • Women who are not within the specified age range for the study.
  • Men cannot participate in this study.
  • Individuals who are considered part of a vulnerable population, which means they might need special protection or care, are not included.
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Investigated drugs

  • Intravenous Iron

    is a treatment where iron is delivered directly into the bloodstream through a vein. This method is used to quickly increase iron levels in the body, which can be beneficial for individuals with significant iron deficiency. In this trial, intravenous iron is being tested to see if it helps reduce the risk of postpartum depression in women who have moderate iron deficiency anemia after a cesarean delivery.

  • Oral Iron

    is a treatment where iron is taken by mouth in the form of tablets or capsules. This is a common way to treat iron deficiency anemia, as it helps to gradually increase iron levels in the body. In this trial, oral iron is being compared to intravenous iron to determine its effectiveness in reducing postpartum depression in women with moderate iron deficiency anemia after a cesarean delivery.

What is already known about the treatment

  • Intravenous Iron

    This medication is administered through an IV infusion, directly into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating moderate postpartum iron deficiency anemia in women who have undergone a cesarean delivery. The main therapeutic indication is to replenish iron levels in the body, which can help alleviate symptoms of anemia and potentially reduce the risk of postpartum depression. At the molecular level, intravenous iron works by providing a direct source of iron, which is essential for the production of hemoglobin, a protein in red blood cells that carries oxygen. It is classified as an iron supplement.

  • Oral Iron

    This medication is taken by mouth in the form of tablets or capsules. It is also being evaluated in clinical trials for its role in treating moderate postpartum iron deficiency anemia in women after cesarean delivery. The primary therapeutic use is to increase iron levels in the body, which may help improve anemia symptoms and decrease the likelihood of postpartum depression. On a molecular level, oral iron is absorbed through the digestive tract and used by the body to produce hemoglobin. It falls under the pharmacological classification of iron supplements.

Investigated diseases

  • Postpartum Iron Deficiency Anemia

    This condition occurs in women who have given birth via caesarean section and experience a moderate deficiency in iron levels after delivery. It is characterized by low hemoglobin levels, typically between 8.0 g/dL and 10.0 g/dL, within 72 hours postpartum. Additionally, affected individuals may have low ferritin levels or low transferrin saturation, indicating insufficient iron stores in the body. This deficiency can lead to symptoms such as fatigue, weakness, and pallor. The condition is common and not classified as a rare disease. It is important to monitor and manage iron levels to support recovery and overall health after childbirth.

  • Postpartum Depression

    This mental health condition can affect women after childbirth, characterized by feelings of sadness, anxiety, and fatigue that interfere with daily life. It typically develops within the first few weeks postpartum but can occur up to a year after delivery. Symptoms may include mood swings, irritability, difficulty bonding with the baby, and changes in appetite or sleep patterns. The condition is assessed using tools like the Edinburgh Postnatal Depression Scale (EPDS), with scores indicating the severity of symptoms. It is important to recognize and address postpartum depression to support the well-being of both the mother and the child.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503283-17-00Protocol codeAPHP220806Estimated enrolment2 860 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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