产后缺铁性贫血的预防 (PRIORITY)
2026年6月29日 更新者：NICHD Global Network for Women's and Children's Health
预防产后缺铁性贫血（优先试验）：全球妇女和儿童健康研究网络的随机对照试验
PRIORITY 被设计为一项针对产后妇女的双臂随机对照试验。
该试验将招募根据分娩后 6-48 小时采集的血样被诊断患有中度贫血的妇女。
共有 4,800 名符合条件的女性，或每个研究中心 600 名女性，将获得同意并参加试验。
该研究假设，在分娩后 6 周，在分娩后 6 至 48 小时和出院前接受单剂量静脉铁剂输注的女性中非贫血状态的患病率将高于给予女性口服补铁药片，每天服用两次，持续 6 周。
研究概览
地位
完全的
条件
详细说明
PRIORITY 是一项双臂随机对照试验，将在 7 个国家/地区的 8 个地点实施：孟加拉国、刚果民主共和国、危地马拉、印度（那格浦尔和 Belagavi）、肯尼亚、巴基斯坦和赞比亚。
每个站点的研究团队将招募大约 600 名在医院或其他设施（例如提供分娩服务的健康中心）分娩的妇女。
参与者将在分娩后 6 至 48 小时内随机接受单剂量静脉铁输注，然后出院或每天服用两次口服铁片，持续 6 周。
然后，研究人员将在分娩后 6 周和 6 个月时在适当的医疗机构对他们进行评估，方法是提供母体血液样本，分析以确定 Hb 浓度。
在每次研究访问中，经过培训的工作人员还将测量血清铁蛋白、血清转铁蛋白受体、C 反应蛋白 (CRP) 和 α1 酸性糖蛋白 (AGP)。
此外，在非洲研究地点，将在进入分娩机构时以及产后 6 周和 6 个月时进行疟疾快速诊断测试 (RDT)。
还将使用爱丁堡产后抑郁量表 (EPDS)、世界卫生组织生活质量 (QOL) 量表、产妇疲劳严重程度量表 (FSS-5R) 和母婴关系量表 (MIBS)在产后 6 周和 6 个月进行随访，以收集次要研究目标的数据。该研究假设，在分娩后 6 周，接受单剂量静脉铁剂输注的女性中非贫血状态的患病率分娩后 6 至 48 小时和出院前的铁摄入量将高于连续 6 周每天服用两次口服铁片的妇女。
次要研究目标将着眼于产后抑郁症对产妇生活质量、疲劳以及母乳喂养开始和保留率的影响。
抑郁症也是减少母婴关系的一个危险因素。
研究类型
介入性
注册 (实际的)
4857
阶段
- 第三阶段
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。
学习地点
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Kinshasa、刚果民主共和国
- Kinshasa School of Public Health
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India
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Nagpur、India、印度
- Lata Medical Research Foundation
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Karnataka
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Belagavi、Karnataka、印度、590 010
- KLE Society's Jawaharlal Nehru Medical College
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Guatemala City、危地马拉
- INCAP
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Dhaka、孟加拉国、1212
- Icddrb
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Pakistan
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Karachi、Pakistan、巴基斯坦、74800
- The Aga Khan University
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Eldoret、肯尼亚、30100
- Moi University School of Medicine
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Lusaka、赞比亚
- University Teaching Hospital
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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
15年 至 49年 (孩子、成人)
接受健康志愿者
不
描述
纳入标准：
- 通过 LMP 和/或临床评估和/或 USG 确定妊娠 >20 周妊娠
- 年龄：15 岁（或符合条件的下限年龄*）至 49 岁
- 确诊中度贫血（Hb 7.0 至 9.9 g/dL，分娩后 6-48 小时，基于 Hemocue® 上的静脉血样）
- 在参与研究的医院或医疗机构分娩
- 能够提供知情同意
- 计划在研究期间留在研究区域
排除标准：
- 过去 3 周内接受过 IV 铁剂输注
- 补铁禁忌症（一些例子可能包括溶血性贫血、过敏、严重感染）
- 在当前入院期间已经接受或计划输血
- 已知诊断为先前存在的抑郁症或其他精神疾病
- 死产、主要先天性异常或随机分组前的新生儿丢失
- 女性疟疾测试呈阳性且以前未接受过疟疾治疗
- 出现症状性贫血伴呼吸困难或疲劳，需要立即纠正
- 患有已知血红蛋白病（镰状细胞病或地中海贫血）的女性
- 存在严重的过敏性疾病，例如严重的哮喘或已知的药物过敏
- 根据医生的评估，患有任何需要立即就医的疾病/病症的女性
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：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：IV iron infusion
Participants randomized to the IV iron arm will receive a single-dose infusion of IV FCM, to be initiated between 6-48 hours after delivery.
All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.
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FCM 50 mg iron/mL will be in a solution of 20 mL vials for infusion, using a dosage of 20 mg elemental iron per kg body weight, up to a maximum of 1 g, in a single IV infusion over 20-30 minutes.
400 mcg of folic acid daily to 6 months.
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有源比较器：Oral iron tablets
Participants randomized to the oral iron arm will receive 60 mg elemental iron twice daily.
Treatment will be initiated between 6-48 hours after delivery and prior to discharge from the facility.
After discharge, each participant will take a treatment dose of twice daily for 6 weeks postpartum.
At 6 weeks postpartum, serum Hb will be assessed and participants with Hb < 7.0 g/dL will stop treatment, participants with Hb 7.0-11.9
g/dL will continue taking 60 mg elemental iron twice daily and participants with Hb > 11.9 g/dL will take 60 mg elemental iron once daily.
All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.
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60 mg elemental iron twice daily to 6-weeks with then once or twice daily (based on Hb at 6-weeks) to 6-months.
400 mcg of folic acid daily to 6 months.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Maternal non-anemic state (Hb ≥11 g/dL)
大体时间：6 weeks post-delivery
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6 weeks post-delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in serum Hb concentration at 6-weeks postpartum
大体时间：6 weeks post-delivery
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Serum Hb at baseline subtracted from serum Hb at 6 weeks.
Key secondary outcome.
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6 weeks post-delivery
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Maternal depression at 6-weeks postpartum
大体时间：6 weeks post-delivery
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Measured by Edinburgh Postnatal Depression Scale score > 10.
A score greater than 10 indicates a higher likelihood of depression.
Key secondary outcome.
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6 weeks post-delivery
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Change from baseline in serum Hb concentration at 6-months postpartum
大体时间：6 months post-delivery
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Serum Hb at baseline subtracted from serum Hb at 6 months.
Key secondary outcome.
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6 months post-delivery
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Maternal depression at 6-months postpartum
大体时间：6 months post-delivery
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Measured by Edinburgh Postnatal Depression (EPDS) Scale score > 10.
A score greater than 10 indicates a higher likelihood of depression.
Key secondary outcome.
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6 months post-delivery
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Maternal Fatigue Severity Scale Score > 4
大体时间：6 weeks and 6 months post-delivery
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Measured by the Maternal Fatigue Severity Scale (FSS-5R) > 4. A score > 4 indicates maternal fatigue.
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6 weeks and 6 months post-delivery
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Mother-to-Infant Bonding Scale Score ≥ 4
大体时间：6 weeks post-delivery
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Measured by the Mother-to-Infant Bonding Scale (MIBS) ≥ 4. A score ≥ 4 indicates worse mother to infant bonding.
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6 weeks post-delivery
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WHOQOL-BREF Overall Perception of Quality of Life score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF overall perception of quality of life score is the response to question 1 from the WHOQOL-BREF survey.
How would you rate your quality of life?
(Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
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6 weeks and 6 months post-delivery
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WHOQOL-BREF Overall Perception of Health score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF overall perception of heath score is the response to question 2 from the WHOQOL-BREF survey.
How satisfied are you with your health?
(Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
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6 weeks and 6 months post-delivery
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WHOQOL-BREF Physical Domain Score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF physical domain score is calculated as: ((6-Q3) + (6-Q4) + Q10 + Q15 + Q16 + Q17 + Q18)/7 x 4. If a participant is missing 2 or more questions in the physical domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF physical domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Psychological Domain Score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF psychological domain score is calculated as: (Q5 + Q6 + Q7 + Q11 + Q19 + (6-Q26))/6 x 4. If a participant is missing 2 or more questions in the psychological domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF psychological domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Social Relationships Domain Score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF social relationships domain score is calculated as: (Q20 + Q21 + Q22)/3 x 4. If a participant is missing 2 or more questions in the social relationships domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF social relationships domain score is set to missing. In the case where one item is missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Environment Domain Score
大体时间：6 weeks and 6 months post-delivery
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The WHOQOL-BREF environment domain score is calculated as: (Q8 + Q9 + Q12 + Q13 + Q14 + Q23 + Q24 + Q25)/8 x 4. If a participant is missing 3 or more questions in the environment domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF environment domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing questions. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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Change from baseline in serum ferritin concentration
大体时间：6 weeks and 6 months post-delivery
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Serum ferritin concentration at baseline subtracted from serum ferritin concentration at 6 weeks and 6 months.
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6 weeks and 6 months post-delivery
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Change from baseline in serum soluble transferrin receptor concentration
大体时间：6 weeks and 6 months post-delivery
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Serum soluble transferrin receptor at baseline subtracted from serum soluble transferrin receptor at 6 weeks and 6 months.
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6 weeks and 6 months post-delivery
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Maternal non-anemic state (Hb ≥11.5 g/dL)
大体时间：6 weeks and 6 months post-delivery
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6 weeks and 6 months post-delivery
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Maternal non-anemic state (Hb ≥12.0 g/dL)
大体时间：6 weeks and 6 months post-delivery
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6 weeks and 6 months post-delivery
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Anemic state
大体时间：6 weeks and 6 months post-delivery
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Anemic state at 6 weeks postpartum defined as no anemia for Hb ≥ 11.0 g/dL, mild anemia for Hb 10.0-10.9
g/dL, moderate anemia for 7.0-9.9
g/dL and severe anemia for Hb < 7.0 g/dL.
Anemic state at 6 months postpartum defined as no anemia for Hb ≥ 12.0 g/dL, mild anemia for Hb 10.0-11.9
g/dL, moderate anemia for 7.0-9.9
g/dL and severe anemia for Hb < 7.0 g/dL.
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6 weeks and 6 months post-delivery
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Change from baseline in anemic state
大体时间：6 weeks and 6 months post-delivery
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Defined as 'Better' if the participant's Hb measurement is > 9.9 g/dL, 'No change' if the participant's Hb measurement is 7.0-9.9
g/dL, and 'Worse' if the participant's Hb measurement is < 7.0 g/dL.
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6 weeks and 6 months post-delivery
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Maternal mortality
大体时间：randomization to 6 months post-delivery
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Maternal death from any cause
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randomization to 6 months post-delivery
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Post-discharge blood transfusion
大体时间：discharge from delivery facility to 6 months post-delivery
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Blood transfusion given to mother after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Postpartum hemorrhage requiring blood transfusion or major surgery
大体时间：randomization to 6 weeks post-delivery
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randomization to 6 weeks post-delivery
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Post-discharge maternal hospitalization
大体时间：discharge from delivery facility to 6 months post-delivery
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Maternal admission to facility after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Neonatal/infant mortality
大体时间：randomization to 6 months
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Neonatal/infant death from any cause
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randomization to 6 months
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Post-discharge neonatal/infant hospitalization
大体时间：discharge from delivery facility to 6 months post-delivery
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Neonatal/infant admission to facility after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Exclusive breastfeeding
大体时间：6 weeks, 3 months and 6 months post-delivery
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Based on WHO/UNICEF definition that measures exclusive feeding with breast milk during the previous day.
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6 weeks, 3 months and 6 months post-delivery
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Hypophosphatemia at 6-weeks postpartum
大体时间：6 weeks post-delivery
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Measured by serum phosphate concentration < 2.5 mg/dL.
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6 weeks post-delivery
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Hypophosphatemia at 6-months postpartum
大体时间：6 months post-delivery
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Measured by serum phosphate concentration < 2.5 mg/dL at 6 months among participants with hypophosphatemia at 6 weeks.
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6 months post-delivery
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Short-term safety outcomes
大体时间：randomization to 6 weeks post-delivery
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Measured by at least one serious adverse event reported.
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randomization to 6 weeks post-delivery
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All Safety outcomes
大体时间：randomization to 6 months post-delivery
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Measured by at least one serious adverse event reported.
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randomization to 6 months post-delivery
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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。
合作者
调查人员
- 首席研究员：Richard J Derman, MD, MPH、Thomas Jefferson University, Philadelphia, PA
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Jessani S, Saleem S, Hoffman MK, Goudar SS, Derman RJ, Moore JL, Garces A, Figueroa L, Krebs NF, Okitawutshu J, Tshefu A, Bose CL, Mwenechanya M, Chomba E, Carlo WA, Das PK, Patel A, Hibberd PL, Esamai F, Liechty EA, Bucher S, Nolen TL, Koso-Thomas M, Miodovnik M, McClure EM, Goldenberg RL. Association of haemoglobin levels in the first trimester and at 26-30 weeks with fetal and neonatal outcomes: a secondary analysis of the Global Network for Women's and Children's Health's ASPIRIN Trial. BJOG. 2021 Aug;128(9):1487-1496. doi: 10.1111/1471-0528.16676. Epub 2021 Apr 12.
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- Skevington SM. Measuring quality of life in Britain: introducing the WHOQOL-100. J Psychosom Res. 1999 Nov;47(5):449-59. doi: 10.1016/s0022-3999(99)00051-3.
- Auerbach M, Macdougall I. The available intravenous iron formulations: History, efficacy, and toxicology. Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92. doi: 10.1111/hdi.12560. Epub 2017 Mar 29.
- Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006 Feb;21(2):378-82. doi: 10.1093/ndt/gfi253. Epub 2005 Nov 11.
- Gomez-Ramirez S, Shander A, Spahn DR, Auerbach M, Liumbruno GM, Vaglio S, Munoz M. Prevention and management of acute reactions to intravenous iron in surgical patients. Blood Transfus. 2019 Mar;17(2):137-145. doi: 10.2450/2018.0156-18. Epub 2018 Oct 16.
- Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Szebeni J, Weiss G. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014 Nov;99(11):1671-6. doi: 10.3324/haematol.2014.111492.
- Auerbach M, Macdougall IC. Safety of intravenous iron formulations: facts and folklore. Blood Transfus. 2014 Jul;12(3):296-300. doi: 10.2450/2014.0094-14. No abstract available.
- Rebecca Giallo, Catherine Wade & Mandy Kienhuis (2014) Fatigue in mothers of infants and young children: factor structure of the fatigue assessment scale, Fatigue: Biomedicine, Health & Behavior, 2:3, 119-131, DOI: 10.1080/21641846.2014.925326
- Young CA, Mills R, Al-Chalabi A, Burke G, Chandran S, Dick DJ, Ealing J, Hanemann CO, Harrower T, Mcdermott CJ, Majeed T, Pinto A, Talbot K, Walsh J, Williams TL, Tennant A; TONiC study group. Measuring quality of life in ALS/MND: validation of the WHOQOL-BREF. Amyotroph Lateral Scler Frontotemporal Degener. 2020 Jun 27;21(5-6):364-372. doi: 10.1080/21678421.2020.1752244.
有用的网址
- Sison G. The Morisky Medication Adherence Scale: An Overview. 2018
- Auerbach M. Treatment of iron deficiency anemia in adults. 2020
- Electronic Medicines Compendium (eMC). Monofer 100mg/ml solution for injection/infusion.
- Electronic Medicines Compendium (eMC). Ferinject (ferric carboxymaltose).
- World Health Organization. Anemia
- World Health Organization. Maternal health
- Number of non-pregnant women (aged 15-49 years) with anaemia (thousands)
- World Health Organization. Prevalence of anaemia in pregnant women (aged 15-49) (%).
- World Health Organization. Prevalence of anaemia in women of reproductive age (aged 15-49) (%)
- World Health Organization. The World Health Organization Quality of Life (WHOQOL). 2012.
- World Health Organization. WHA65.6. Comprehensive implementation plan on maternal, infant and young child nutrition as passed by the World Health Assembly at the Sixty-fifth World Health Assembly meeting.2012.
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)
2023年5月30日
初级完成 (实际的)
2025年3月10日
研究完成 (实际的)
2025年7月28日
研究注册日期
首次提交
2022年9月29日
首先提交符合 QC 标准的
2022年10月19日
首次发布 (实际的)
2022年10月21日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.