このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

静脈内鉄と経口鉄および産後うつ病による帝王切開後の貧血の治療 (IRON-DEP)

2026年9月18日 更新者：Assistance Publique - Hôpitaux de Paris

静脈内鉄と経口鉄および産後うつ病を伴う帝王切開後の貧血の治療：多室中心の無作為化された無標識対照試験

The objectif of the IRON-DEP Study is to assess the efficacy of intravenous (IV) versus oral iron treatment on the prevalence of postpartum depression (PPD) in women with moderate iron deficiency anemia after caesarean delivery.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

PPD is a frequent (10-20% of delivery) and serious condition that has a detrimental impact on both maternal and child health by altering the quality of their interactions. Moreover, it is a significant risk factor for suicide, which is the leading cause of maternal death.

The increased risk of PPD in women with postpartum anemia has been documented. Women who delivered by cesarean are particularly vulnerable to this risk as this mode of delivery is a risk factor for both postpartum anaemia and postpartum depression. Therefore, correcting anemia and preventing PPD in this population represent a major public health priority.

First line treatment recommended for iron deficiency moderate anaemia (8.0g/dL≤ Hb ≤10.0g/dL) is oral iron. However oral iron is associated with very frequent adverse effects, contributing to poor tolerance and compliance of this treatment. Actually, IV iron is indicated in women with non-severe postpartum anaemia with lack of response or intolerance to oral iron treatment. There is growing interest in the use of intravenous iron and several randomized controlled trials demonstrated that IV iron is significantly more efficient than oral iron supplementation to correct moderate postpartum anaemia and increase haemoglobin level. However, none of them compared the efficacy of IV iron versus oral iron on postpartum depression as a primary outcome.

The hypothesis of the IRON-DEP Study is that, among women with moderate postpartum iron deficiency anaemia after caesarean delivery, the prevalence of PPD symptoms at 8 weeks after delivery is lower in women treated with IV iron than in those treated with oral iron.

The IRON-DEP trial is a phase IV national multicenter comparative randomized controlled superiority open-label trial with 2 parallel groups.

Implementation of the study :

  • 24 french maternity units will be participating
  • Women who delivered by cesarean admitted in the postpartum maternity ward, with postpartum anaemia will be screened to check the inclusion and exclusion criteria.
  • The investigator will inform the eligible patient about the protocol and obtain the written consent
  • The randomization will take place during the hospitalization for caesarean delivery and will be stratified on the centre and on the initial severity of post-partum anemia (according to the postpartum hemoglobin level).
  • IV iron will be administered during hospitalization and participants in the oral iron group will start their treatment during their hospitalization for 8 weeks treatment.
  • A follow up visit at 8 weeks postpartum will be planned at the maternity unit for all participants
  • All participants will fill in self-assessment questionnaires (online or paper form) at inclusion, 8 weeks and 6 months postpartum follow up.

研究の種類

介入

入学 (推定)

2860

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • フランス
      • Paris、フランス、75012
        • 募集
        • CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

Pre-inclusion criteria:

  • Age ≥18 years
  • Caesarean delivery (elective or in emergency)
  • Gestational age at delivery ≥ 32 weeks
  • 8.0 g/dL ≤ postoperative Hb level ≤ 10.0 g/dL measured within 72 hours postpartum
  • Informed consent form signed
  • Hospitalization in the postpartum maternity ward
  • National social security coverage including AME

Inclusion criteria:

  • Ferritinemia ≤ 100 ng/mL OR transferrin saturation ≤ 20% measured after postoperative Hb level measurement
  • EPDS score in the immediate postpartum <13 with a "never" answer to question n°10

Exclusion Criteria:

  • Stillbirth or neonatal death

  • Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) < 35kg or > 100kg

  • Biermer disease

  • Hemochromatosis

  • Homozygous sickle cell disease or thalassemia

  • Chronic iron supplementation (outside pregnancy)

  • Known hypersensitivity or allergy to the studied drugs (IV or oral iron)

  • Contra-indication to the studied drugs (IV or oral iron)

  • Severe asthma (with daily background treatment)

  • Any known severe renal or liver disorder

  • Active acute infection

  • Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation

  • Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders

  • Participation in another clinical trial involving an intervention with the following risks:

    • A change (increase or decrease in value) in Haemoglobin measured at 2 months postpartum OR
    • A change in EPDS score measured at 2 and 6 months postpartum OR
    • A trial exploring an intervention with a specific anaphylactic risk (reported as a potential adverse events in the protocol of the other trial) administered during the postpartum hospitalization period.

  • Poor understanding of the French language

  • Legal protection (curatorship or tutorship)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：ヘルスサービス研究
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
実験的：Intravenous iron

Women in the experimental arm will receive an IV iron infusion within 5 days after delivery
アクティブコンパレータ：Oral iron

Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
時間枠：8 weeks postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire at 8 weeks.

The primary measure of treatment effect will be based on the 'treatment policy' estimand: the effect will be measured by including all women who participated in the study, according to the initial randomization, regardless of the treatment they actually received or their adherence to the treatment. If the 8-week value is not observed, these participants will be included in the analysis after imputing their missing value.

Secondary measures of treatment effect will be implemented based on the "principal stratum strategy" estimand: the effect will be measured in women according to the treatment they actually received and in those who achieved a compliance rate of over 80%.

The estimands discussed above will be applied to all efficacy-related criteria. For safety-related criteria, only the second estimand (principal stratum strategy) will be considered.
8 weeks postpartum

二次結果の測定

結果測定
メジャーの説明
時間枠
The mean Haemoglobin (Hb) level
時間枠：8 weeks postpartum

All participants will have à haemoglobin measurment at 8 weeks
8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level
時間枠：At Inclusion and at 8 weeks postpartum

Haemoglobin measurment at 8 weeks
At Inclusion and at 8 weeks postpartum
The proportion of women with Haemoglobin level < 12.0 g/dL
時間枠：8 weeks postpartum

Haemoglobin measurment at 8 weeks
8 weeks postpartum
The mean ferritinemia level
時間枠：At Inclusion and at 8 weeks postpartum

Ferritinemia dosage at 8 weeks
At Inclusion and at 8 weeks postpartum
The mean change in ferritinemia level
時間枠：At Inclusion and at 8 weeks postpartum

Ferritinemia dosage at 8 weeks
At Inclusion and at 8 weeks postpartum
The proportion of women with ferritinemia < 20 ng/mL
時間枠：8 weeks postpartum

Ferritinemia dosage at 8 weeks
8 weeks postpartum
Mean EPDS score
時間枠：8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
時間枠：8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
時間枠：8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean change in EPDS score
時間枠：8 weeks postpartum, 6 months postpartum

Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The need for red blood cell transfusion
時間枠：From discharge to 8 weeks postpartum

The variable of interest is whether (yes or no) a patient received a red blood cell transfusion. The summary measure of the effect is the percentage of patients who were transfused.
From discharge to 8 weeks postpartum
The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
時間枠：8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire ( overall and in each of its 5 dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue).
8 weeks postpartum, 6 months postpartum
The proportion of women with high fatigue score (MIF-20 score>15)
時間枠：8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean relative change in MFI-20 scores
時間枠：8 weeks postpartum, 6 months postpartum

Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
時間枠：8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportion of women with MIBS≥2
時間枠：8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The proportion of breastfeeding women and mean duration for those who stopped
時間枠：8 weeks postpartum, 6 months postpartum

Participants will answer self assessment questionnaires
8 weeks postpartum, 6 months postpartum
The mean relative change in MIBS score
時間枠：8 weeks postpartum, 6 months postpartum

Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire
8 weeks postpartum, 6 months postpartum
The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
時間枠：8 weeks postpartum, 6 months postpartum

EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels) overall and for each of the 5 dimensions
8 weeks postpartum, 6 months postpartum
The number of women in each group who also received the other group treatment within 8 weeks postpartum
時間枠：Up to 8 weeks

Women who needed IV iron in the oral iron group because of poorly tolerated anaemia, and women who took oral iron after hospital discharge in the IV iron group
Up to 8 weeks
Assessement of adverse events
時間枠：From first drug administration to 8 weeks

Incidence, nature, and severity of adverse events and serious adverse events
From first drug administration to 8 weeks
Compliance to treatment for participants in the oral iron arm
時間枠：8 weeks

Good compliance defined by the overall drug intake >80% of the prescribed oral iron treatment
8 weeks
Total costs of healthcare resources for medicoeconomic cost-consequence analysis
時間枠：Up to 6 months postpartum

Use of resources and consequences for women are collected prospectively from the time of randomization up to 6 months by a a self-assessment questionnaire at 8 weeks and 6 months
Up to 6 months postpartum

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Assistance Publique - Hôpitaux de Paris

捜査官

  • 主任研究者：Marie-Pierre BONNET, MD, PhD、Assistance Publique - Hôpitaux de Paris
  • スタディディレクター：Catherine DENEUX-THARAUX, MD, PhD、Assistance Publique - Hôpitaux de Paris

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月22日

一次修了 (推定)

2028年6月22日

研究の完了 (推定)

2028年10月30日

試験登録日

最初に提出

2025年2月13日

QC基準を満たした最初の提出物

2025年2月13日

最初の投稿 (実際)

2025年2月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • APHP220806
  • 2023-503283-17-00 (Ctis)
  • 2023 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する