补充阿司匹林可降低未产妇的妊娠风险 (ASPIRIN) (ASPIRIN)
研究概览
详细说明
背景:早产 (PTB) 仍然是发达国家和发展中国家新生儿死亡和长期残疾的主要原因。 尽管起源复杂,但越来越多的证据表明,妊娠早期服用低剂量阿司匹林 (LDA) 有望大幅降低 PTB 的发生率。
假设:研究人员的主要假设是,从 6 0/7 周至 13 6/7 周胎龄 (GA) 至 36 0/7周 GA 将降低各种原因引起的早产风险。
研究设计类型:前瞻性随机、安慰剂对照、双盲多中心临床试验(患者水平 1:1)。
人群:年龄在 18 岁(或当地法定年龄)至 40 岁之间且前三个月流产不超过两次或任何妊娠中期自发流产的未生育妇女,单胎妊娠在 6 0/7 周至 13 6/7 周之间周经超声证实GA,无阿司匹林禁忌症。 根据现场调查员的判断,其他医疗条件,如镰状细胞性贫血,可能被视为禁忌症。
干预:每日服用低剂量 (81 mg) 阿司匹林 [也称为乙酰水杨酸 (ASA)],在 GA 6 0/7 周至 13 6/7 周之间开始,并持续至 36 0/7 周 GA 与相同出现安慰剂。 合规性和结果将每两周评估一次。
结果:
主要结果是确定每日 LDA 是否在 6 0/7 周和 13 6/7 周之间开始并持续到 36 0/7 周将早产(妊娠 37 0/7 周之前出生)的风险降低 20 %。 这将根据评估的分娩日期与预计的分娩日期进行比较来确定,而不管早产是预示的还是自发的。
次要结果包括:
- 先兆子痫和子痫(妊娠期高血压疾病)
- 小于胎龄儿
- 围产儿死亡率
其他感兴趣的次要结果是:
产妇结局:
- 阴道流血
- 产前出血
- 产后出血
- 孕产妇死亡率
- 晚期流产
- 母体血红蛋白的变化
- 早产、先兆子痫
胎儿结局:
- 早产 < 妊娠 34 0/7 周
- 出生体重 <2500g 和 <1500g
- 胎儿丢失
- 自然流产
- 死胎
- 医学终止妊娠
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
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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Nagpur、印度
- Lata Medical Research Foundation
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Karnataka
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Belgaum、Karnataka、印度
- KLE University's Jawaharlal Nehru Medical College
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Guatemala City、危地马拉、01015
- Institute of Nutrition of Central America and Panama (INCAP)
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Karachi、巴基斯坦、74800
- The Aga Khan University
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Alabama
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Birmingham、Alabama、美国、35233
- University of Alabama, Birmingham
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Colorado
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Denver、Colorado、美国、80045
- University of Colorado, Denver
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
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Massachusetts
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Boston、Massachusetts、美国、02215
- Boston University
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New York
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New York、New York、美国、10032
- Columbia University
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina, Chapel Hill
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson 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
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 18-40岁之间的未生育妇女。 如果国家/地区的道德准则允许,年龄≥ 14 岁的未成年人可以入组。
- 前三个月流产不超过两次
- 没有服用阿司匹林的医学禁忌症;
- 6 0/7 和 13 6/7 周 GA 之间的单活宫内妊娠 (IUP) 由早期约会超声和心跳的存在证实。
排除标准:
- 妇女每天服用阿司匹林超过 7 天;
- 多胎妊娠;
- 超声检查胎儿异常(请注意,在妊娠早期进行的超声检查无法检测到大多数胎儿异常。 随后发现胎儿异常不被视为排除。)
- 筛选时血红蛋白 < 7.0 gm/dl;
- 根据现场调查员的判断可能被视为禁忌症的任何其他医疗状况(例如,狼疮、1 型糖尿病或任何其他已知的重大疾病)
- 血压≥140/90(筛选时收缩压≥140,舒张压≥90)
学习计划
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:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:干预臂
从 GA 6 0/7 周到 13 6/7 周开始,一直持续到 GA 36 0/7 周,女性将被随机分配接受每日 81 mg 的低剂量阿司匹林 (LDA) [也称为乙酰水杨酸 (ASA)]或送货。
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每日服用低剂量 (81 mg) 阿司匹林 [也称为乙酰水杨酸 (ASA),在 GA 6 0/7 周至 13 6/7 周之间开始,并持续至 GA 36 0/7 周,与出现相同的安慰剂相比。
合规性和结果将每两周评估一次。
其他名称:
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安慰剂比较:安慰剂组
从 GA 6 0/7 周到 13 6/7 周之间开始并一直持续到 GA 36 0/7 周或分娩,女性将被平均随机分配接受相同的安慰剂。
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安慰剂
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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 |
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早产发生率
大体时间:交货时
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本研究的主要结果是早产率,早产定义为在 20 0/7 周或之后以及 37 0/7 周之前分娩。
这将根据与预计预产期 (EDD) 相比的实际分娩日期来确定,而不管早产是预示的还是自发的。
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交货时
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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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妊娠期高血压疾病的发病率
大体时间:妊娠期间高血压疾病的证据(分娩/分娩前)
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- 妊娠高血压疾病的定义是有高血压疾病证据的特征,包括妊娠期间发生的先兆子痫或子痫。
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妊娠期间高血压疾病的证据(分娩/分娩前)
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小于胎龄儿 (SGA) 的发生率
大体时间:分娩时或分娩后第 42 天
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- 根据 INTERGROWTH-21st 标准定义的小于胎龄儿 (SGA)
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分娩时或分娩后第 42 天
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围产儿死亡率
大体时间:分娩时或分娩后第 42 天
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- 围产儿死亡率
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分娩时或分娩后第 42 天
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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产妇结局 1 - 阴道出血的发生率
大体时间:分娩时或分娩后第 42 天
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- 阴道出血
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分娩时或分娩后第 42 天
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产妇结局 2 - 产前出血的发生率
大体时间:分娩时或分娩后第 42 天
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- 产前出血
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分娩时或分娩后第 42 天
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产妇结局 3 - 产后出血的发生率
大体时间:分娩时或分娩后第 42 天
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- 产后出血
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分娩时或分娩后第 42 天
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孕产妇结局 4 - 孕产妇死亡率
大体时间:分娩时或分娩后第 42 天
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- 孕产妇死亡率
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分娩时或分娩后第 42 天
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产妇结局 5 - 晚期流产率
大体时间:分娩时或分娩后第 42 天
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- 晚期流产的发生率
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分娩时或分娩后第 42 天
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产妇结局 6 - 产妇血红蛋白的变化
大体时间:入组时、入组后 4 周和 26-30 周 GA。
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妊娠 26-30 周血红蛋白 < 7.0 gm/dl 或从筛选到妊娠 26-30 周下降 3.5+ gm/dl
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入组时、入组后 4 周和 26-30 周 GA。
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孕产妇结局 7 - 早产、先兆子痫的发生率
大体时间:分娩时或分娩后第 42 天
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早期早产(<34 周)和高血压疾病(即先兆子痫)
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分娩时或分娩后第 42 天
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胎儿结局 1 - 早产发生率(<34 周)
大体时间:交货时
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- 早期早产(<34 周)
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交货时
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胎儿结局 2 - 实际出生体重 <2500g 的发生率
大体时间:交货时
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- 出生体重<2500g
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交货时
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胎儿结局 3 - 实际出生体重 <1500g 的发生率
大体时间:交货时
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- 出生体重 <1500 克
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交货时
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胎儿结局 4 - 胎儿丢失的发生率
大体时间:交货时
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- 胎儿丢失的发生率
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交货时
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胎儿结局 5 - 自然流产的发生率
大体时间:交货时
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- 自然流产的发生率
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交货时
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胎儿结局 6 - 所有死产的发生率
大体时间:交货时
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- 所有死产的发生率
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交货时
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胎儿结局 7 - 医学终止妊娠的发生率
大体时间:交货时
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- 医学终止妊娠的发生率
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交货时
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合作者和调查者
调查人员
- 研究主任:Marion Koso-Thomas, MD、Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
出版物和有用的链接
一般刊物
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- Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, Lokangaka A, Tshefu A, Bose CL, Mwapule A, Mwenechanya M, Chomba E, Carlo WA, Chicuy J, Figueroa L, Garces A, Krebs NF, Jessani S, Zehra F, Saleem S, Goldenberg RL, Kurhe K, Das P, Patel A, Hibberd PL, Achieng E, Nyongesa P, Esamai F, Liechty EA, Goco N, Hemingway-Foday J, Moore J, Nolen TL, McClure EM, Koso-Thomas M, Miodovnik M, Silver R, Derman RJ; ASPIRIN Study Group. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jan 25;395(10220):285-293. doi: 10.1016/S0140-6736(19)32973-3. Erratum In: Lancet. 2020 Mar 21;395(10228):e53.
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安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的