Ferric carboxymaltose IV 和 TIMOFÉROL® 在产后抑郁症（PPD）-临床试验注册中心-ICH GCP

研究概览

地位

招聘中

条件

产后抑郁症（PPD）

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

2860

阶段

第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Marie-Pierre BONNET, MD, PhD
电话号码：(+) 33 1 71 73 89 56
邮箱：marie-pierre.bonnet@aphp.fr

研究联系人备份

姓名：Sarra POCHON, MD
电话号码：0033 1 42 16 75 74
邮箱：sarra.pochon@aphp.fr

学习地点

法国
- - Paris、法国、75012
    - 招聘中
    - CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：卫生服务研究
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

2

武器和干预

参与者组/臂
实验性的：Intravenous iron Women in the experimental arm will receive an IV iron infusion within 5 days after delivery
有源比较器：Oral iron Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11 大体时间：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

次要结果测量

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assistance Publique - Hôpitaux de Paris

调查人员

首席研究员：Marie-Pierre BONNET, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究主任：Catherine DENEUX-THARAUX, MD, PhD、Assistance Publique - Hôpitaux de Paris

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月22日

初级完成 (估计的)

2028年6月22日

研究完成 (估计的)

2028年10月30日

研究注册日期

首次提交

2025年2月13日

首先提交符合 QC 标准的

2025年2月13日

首次发布 (实际的)

2025年2月19日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月18日

最后验证

2026年8月1日

结果测量	措施说明	大体时间
The mean Haemoglobin (Hb) level 大体时间：8 weeks postpartum	All participants will have à haemoglobin measurment at 8 weeks	8 weeks postpartum
Change in postpartum Haemoglobin (Hb) level 大体时间：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 大体时间：8 weeks postpartum	Haemoglobin measurment at 8 weeks	8 weeks postpartum
The mean ferritinemia level 大体时间：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 大体时间：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 大体时间：8 weeks postpartum	Ferritinemia dosage at 8 weeks	8 weeks postpartum
Mean EPDS score 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

剖腹产治疗剖腹产和口服铁和产后抑郁症的贫血 (IRON-DEP)

剖腹产治疗静脉与口服铁和产后抑郁症的贫血：一项多中心随机开放标签对照试验