정맥 내 대 구강 철 및 산후 우울증으로 제왕 절개 후 빈혈 치료 (IRON-DEP)
정맥 내 대 구강 철 및 산후 우울증을 가진 제왕 절개 후 빈혈 치료 : 다 중심 무작위 개방 표지 대조 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Marie-Pierre BONNET, MD, PhD
- 전화번호: (+) 33 1 71 73 89 56
- 이메일: marie-pierre.bonnet@aphp.fr
연구 연락처 백업
- 이름: Sarra POCHON, MD
- 전화번호: 0033 1 42 16 75 74
- 이메일: sarra.pochon@aphp.fr
연구 장소
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Paris, 프랑스, 75012
- 모병
- CHU Armand -Trousseau, AP-HP Service d'anesthésie-réanimation chirurgicale
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
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Stillbirth or neonatal death
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Last body weight available before inclusion (measured at the end of pregnancy or in postpartum) < 35kg or > 100kg
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Biermer disease
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Hemochromatosis
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Homozygous sickle cell disease or thalassemia
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Chronic iron supplementation (outside pregnancy)
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Known hypersensitivity or allergy to the studied drugs (IV or oral iron)
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Contra-indication to the studied drugs (IV or oral iron)
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Severe asthma (with daily background treatment)
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Any known severe renal or liver disorder
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Active acute infection
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Diagnosis of schizophrenia or physical and intellectual state incompatible with a reliable self-evaluation
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Women currently treated with medication or with Electro Convulsion Therapy (ECT) for depression or bipolar disorders
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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.
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Poor understanding of the French language
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Legal protection (curatorship or tutorship)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
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실험적: Intravenous iron
Women in the experimental arm will receive an IV iron infusion within 5 days after delivery |
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활성 비교기: Oral iron
Women in the comparator arm will receive oral iron supplementation for 8 weeks after delivery |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of PostPartum Depression (PPD) symptoms defined by an Edinburg Postpartum Depression Scale (EPDS) score ≥ 11
기간: 8 weeks postpartum
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The mean Haemoglobin (Hb) level
기간: 8 weeks postpartum
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All participants will have à haemoglobin measurment at 8 weeks |
8 weeks postpartum
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Change in postpartum Haemoglobin (Hb) level
기간: At Inclusion and at 8 weeks postpartum
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Haemoglobin measurment at 8 weeks |
At Inclusion and at 8 weeks postpartum
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The proportion of women with Haemoglobin level < 12.0 g/dL
기간: 8 weeks postpartum
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Haemoglobin measurment at 8 weeks |
8 weeks postpartum
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The mean ferritinemia level
기간: At Inclusion and at 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
At Inclusion and at 8 weeks postpartum
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The mean change in ferritinemia level
기간: At Inclusion and at 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
At Inclusion and at 8 weeks postpartum
|
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The proportion of women with ferritinemia < 20 ng/mL
기간: 8 weeks postpartum
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Ferritinemia dosage at 8 weeks |
8 weeks postpartum
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Mean EPDS score
기간: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportions of participants with moderate depressive symptoms level defined by an EPDS ≥ 11 and <13
기간: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) will be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The proportions of participants with high depressive symptoms level defined by an EPDS ≥13
기간: 8 weeks postpartum, 6 months postpartum
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Edinburg Postpartum Depression Scale (EPDS) wil be measured by a self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The mean change in EPDS score
기간: 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
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The need for red blood cell transfusion
기간: From discharge to 8 weeks postpartum
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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
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The mean fatigue score measured by the Multidimensional Fatigue Inventory score-20 (MFI-20)
기간: 8 weeks postpartum, 6 months postpartum
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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
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The proportion of women with high fatigue score (MIF-20 score>15)
기간: 8 weeks postpartum, 6 months postpartum
|
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The mean relative change in MFI-20 scores
기간: 8 weeks postpartum, 6 months postpartum
|
Multidimensional Fatigue Inventory score-20 (MFI-20) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The mean score for mother and child bonding measured by the Mother to Infant Bonding Scale (MIBS)
기간: 8 weeks postpartum, 6 months postpartum
|
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The proportion of women with MIBS≥2
기간: 8 weeks postpartum, 6 months postpartum
|
Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
|
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The proportion of breastfeeding women and mean duration for those who stopped
기간: 8 weeks postpartum, 6 months postpartum
|
Participants will answer self assessment questionnaires |
8 weeks postpartum, 6 months postpartum
|
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The mean relative change in MIBS score
기간: 8 weeks postpartum, 6 months postpartum
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Mother to Infant Bonding Scale (MIBS) self-assessment questionnaire |
8 weeks postpartum, 6 months postpartum
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The mean score of quality of life measured by EQ-5D-5L (European questionnaire of quality of life, 5 domains, 5 levels)
기간: 8 weeks postpartum, 6 months postpartum
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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
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The number of women in each group who also received the other group treatment within 8 weeks postpartum
기간: Up to 8 weeks
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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
|
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Assessement of adverse events
기간: 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
|
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Compliance to treatment for participants in the oral iron arm
기간: 8 weeks
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Good compliance defined by the overall drug intake >80% of the prescribed oral iron treatment |
8 weeks
|
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Total costs of healthcare resources for medicoeconomic cost-consequence analysis
기간: Up to 6 months postpartum
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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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Marie-Pierre BONNET, MD, PhD, Assistance Publique - Hôpitaux de Paris
- 연구 책임자: Catherine DENEUX-THARAUX, MD, PhD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- APHP220806
- 2023-503283-17-00 (씨티스)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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