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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Akcosuyown Purolwqi Hbspiirk Dl Mgvvgsryz Marseille France
Cttb Dq Nwufd Vandoeuvre Les Nancy France
Gatdxa Hbwnclfobyj Utqdwdfhiztvy Pwcum Pfhbjdtnqbl Em Nnbonjxmysgi Paris France
Hckrpqsa Unjqztmevrdbku Soihxvokzx &guxpun Hcnyioi dw Hlufrzpgctj STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.03.2024

Trial locations

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.

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 ID:
2023-503283-17-00
Protocol code:
APHP220806
Trial Phase:
Therapeutic confirmatory (Phase III)

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