妊娠期 18 0/7 至 22 6/7 周之间可预见性膜破裂 (pPPROM) 后的门诊抗生素
2024年3月14日 更新者:David Hackney MD, MS、University Hospitals Cleveland Medical Center
一项随机、对照、非安慰剂试验,主要评估口服门诊抗生素(即阿奇霉素和阿莫西林)对可预见的胎膜早破后的潜伏期(即胎膜破裂后 28 天内分娩的患者比例)的影响18 0/7 和 22 6/7 周胎龄之间。
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
88
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:Felicia LeMoine, MD
- 电话号码:(216) 983-6606
- 邮箱:felicia.lemoine@uhhospitals.org
研究联系人备份
- 姓名:David Hackney, MD
- 电话号码:(216) 844-3787
- 邮箱:david.hackney@uhhospitals.org
学习地点
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Ohio
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Cleveland、Ohio、美国、44109
- 招聘中
- MetroHealth
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接触:
- Felicia LeMoine, MD
- 电话号码:216-983-6606
- 邮箱:felicia.lemoine@uhhospitals.org
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Cleveland、Ohio、美国、44111
- 尚未招聘
- Cleveland Clinic
-
接触:
- Felicia LeMoine, MD
- 电话号码:216-983-6606
- 邮箱:felicia.lemoine@uhhospitals.org
-
Cleveland、Ohio、美国、44106
- 尚未招聘
- University Hospitals
-
接触:
- Felicia LeMoine, MD
- 电话号码:216-983-6606
- 邮箱:felicia.lemoine@uhhosptials.org
-
-
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
是的
描述
纳入标准:
- 英语会话
- 孕
- 活体,单胎妊娠
- 患者能够提供知情同意
- 胎膜破裂时胎龄在 18 周 0 天和 22 周 6 天之间
- 通过以下任一临床检查结果诊断早产、分娩前胎膜破裂 1) 通过无菌窥器检查观察从宫颈管流出的羊水和/或在阴道内汇集的羊水,2) 基础 pH 值(即硝嗪阳性)测试阴道分泌物,3) 通过显微镜检查确定的干燥阴道分泌物的树枝化(即蕨类植物),和/或 4) 小于 4cm 的羊水指数 (AFI)
排除标准:
- 在 ≥ 18 周和 0 天胎龄时通过超声进行或确认的妊娠约会
- 患者希望中断妊娠或引产
- 已知的主要胎儿异常或非整倍体
- 羊膜腔穿刺术 ≤ 诊断为胎膜破裂后 7 天
- 宫颈环扎放置 ≤ 诊断胎膜破裂后 7 天
- 已知对大环内酯类或青霉素类抗生素过敏或有明显不良反应
- 目前在诊断膜破裂时使用抗生素
- 诊断破膜时或诊断后 24 小时内的阴道出血
- 诊断膜破裂时发热(即体温≥ 38 摄氏度)和/或诊断后的前 24 小时内
- 胎膜破裂诊断时的活动性早产(即与宫颈变化相关的一致收缩模式)和/或诊断后的前 24 小时内
- 宫颈扩张 ≥ 4 cm
- 胎儿部位脱垂超出宫颈内口水平
- 如果在妊娠第 22 周发生破裂,则拒绝在再次入院前完成为期 7 天的全面门诊监测
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:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:抗生素
随机分配到研究的治疗(即抗生素)组的患者将接受为期 7 天的口服阿奇霉素和阿莫西林疗程。
阿奇霉素将在随机分组后立即给予单次 500 毫克剂量(2-250 毫克口服片剂),但在出院回家之前,随后每天服用 1-250 毫克口服片剂,持续 4 天(总共 5 天)。
阿莫西林将以单片 500 毫克口服片剂的形式给药,每天 3 次,持续 7 天,第一剂也在出院回家前给药。
|
阿奇霉素将在随机分组后立即给予单次 500 毫克剂量(2-250 毫克口服片剂),但在出院回家之前,随后每天服用 1-250 毫克口服片剂,持续 4 天(总共 5 天)。
阿莫西林将以单片 500 毫克口服片剂的形式给药,每天 3 次,持续 7 天,第一剂也在出院回家前给药。
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无干预:无抗生素
随机分配到对照组(即没有抗生素组)的患者将根据需要期待治疗的可存活 PPROM 的护理实践标准进行管理。
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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 |
---|---|---|
28天内交货
大体时间:自破裂之日起 28 天
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在诊断出可存活的胎膜早破 (pPPROM) 后 28 天内进行自然分娩或有医学指征的分娩的患者比例
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自破裂之日起 28 天
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
严重孕产妇发病率复合
大体时间:从诊断胎膜破裂到分娩后 6 周
|
患者对严重孕产妇发病率复合的“阳性”比例。
如果诊断出以下任何一项,则患者将被称为严重孕产妇综合发病率“阳性”:产妇败血症、产后出血、产妇入住 ICU、产妇死亡。
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从诊断胎膜破裂到分娩后 6 周
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严重新生儿发病率复合
大体时间:从分娩之日到出院之日(最多 6 个月)
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患者对严重新生儿发病率复合的“阳性”比例。
如果诊断出以下任何一项,新生儿将被称为严重新生儿并发症“阳性”:支气管肺发育不良 (BPD)、肺发育不全、脑室内出血 (IVH) III/IV 级、坏死性小肠结肠炎 (NEC) Bell's II 期或更大,血培养阳性的新生儿败血症,血培养阳性的新生儿肺炎,新生儿死亡。
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从分娩之日到出院之日(最多 6 个月)
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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。
调查人员
- 首席研究员:David Hackney, MD、University Hospitals Cleveland Medical Center
- 首席研究员:Justin Lappen, MD、The Cleveland Clinic
- 首席研究员:Brian Mercer, MD、MetroHealth Hospitals
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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- Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
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- Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Wilson EC, Mathews TJ. Births: final data for 2010. Natl Vital Stat Rep. 2012 Aug 28;61(1):1-72.
- Mathews TJ, MacDorman MF. Infant mortality statistics from the 2006 period linked birth/infant death data set. Natl Vital Stat Rep. 2010 Apr 30;58(17):1-31.
- Muris C, Girard B, Creveuil C, Durin L, Herlicoviez M, Dreyfus M. Management of premature rupture of membranes before 25 weeks. Eur J Obstet Gynecol Reprod Biol. 2007 Apr;131(2):163-8. doi: 10.1016/j.ejogrb.2006.05.016. Epub 2006 Jul 17.
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- Pristauz G, Bauer M, Maurer-Fellbaum U, Rotky-Fast C, Bader AA, Haas J, Lang U. Neonatal outcome and two-year follow-up after expectant management of second trimester rupture of membranes. Int J Gynaecol Obstet. 2008 Jun;101(3):264-8. doi: 10.1016/j.ijgo.2007.12.007. Epub 2008 Mar 4.
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- Russo V, Puzio G, Siniscalchi N. Azithromycin-induced QT prolongation in elderly patient. Acta Biomed. 2006 Apr;77(1):30-2.
- Kezerashvili A, Khattak H, Barsky A, Nazari R, Fisher JD. Azithromycin as a cause of QT-interval prolongation and torsade de pointes in the absence of other known precipitating factors. J Interv Card Electrophysiol. 2007 Apr;18(3):243-6. doi: 10.1007/s10840-007-9124-y. Epub 2007 Jun 2.
- Ailes EC, Gilboa SM, Gill SK, Broussard CS, Crider KS, Berry RJ, Carter TC, Hobbs CA, Interrante JD, Reefhuis J; and The National Birth Defects Prevention Study. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016 Nov;106(11):940-949. doi: 10.1002/bdra.23570.
- Andes D, Craig WA. In vivo activities of amoxicillin and amoxicillin-clavulanate against Streptococcus pneumoniae: application to breakpoint determinations. Antimicrob Agents Chemother. 1998 Sep;42(9):2375-9. doi: 10.1128/AAC.42.9.2375.
- Andrew MA, Easterling TR, Carr DB, Shen D, Buchanan ML, Rutherford T, Bennett R, Vicini P, Hebert MF. Amoxicillin pharmacokinetics in pregnant women: modeling and simulations of dosage strategies. Clin Pharmacol Ther. 2007 Apr;81(4):547-56. doi: 10.1038/sj.clpt.6100126. Epub 2007 Feb 28.
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- Nimrod C, Varela-Gittings F, Machin G, Campbell D, Wesenberg R. The effect of very prolonged membrane rupture on fetal development. Am J Obstet Gynecol. 1984 Mar 1;148(5):540-3. doi: 10.1016/0002-9378(84)90743-9.
- Christianson C, Huff D, McPherson E. Limb deformations in oligohydramnios sequence: effects of gestational age and duration of oligohydramnios. Am J Med Genet. 1999 Oct 29;86(5):430-3.
- Winn HN, Chen M, Amon E, Leet TL, Shumway JB, Mostello D. Neonatal pulmonary hypoplasia and perinatal mortality in patients with midtrimester rupture of amniotic membranes--a critical analysis. Am J Obstet Gynecol. 2000 Jun;182(6):1638-44. doi: 10.1067/mob.2000.107435.
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1月13日
初级完成 (估计的)
2026年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2022年4月14日
首先提交符合 QC 标准的
2022年4月14日
首次发布 (实际的)
2022年4月26日
研究记录更新
最后更新发布 (实际的)
2024年3月15日
上次提交的符合 QC 标准的更新
2024年3月14日
最后验证
2024年3月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY20220251
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
一旦数据收集和初步分析完成。
将提供去识别化的数据集。
IPD 共享时间框架
数据将在研究结果公布后可用,并在研究完成后保留 2 年。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.
阿奇霉素丸的临床试验
-
University of Geneva, SwitzerlandUniversity of Lausanne招聘中
-
Intec Pharma Ltd.未知
-
Intec Pharma Ltd.未知帕金森病美国, 西班牙, 意大利, 以色列, 波兰, 英国, 保加利亚, 德国, 斯洛伐克, 乌克兰