Oxytocin Administration Prior Planned Caesarean Section
追踪信息 | |||
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首次提交日期 ICMJE | September 24, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | January 1, 2019 | ||
预计主要完成日期 | June 30, 2022 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Incidence of neonatal respiratory morbidity[ Time Frame: in the first 4 hours of life ] Percentage of infants to be monitored or admitted to neonatology for respiratory distress syndrome |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Oxytocin Administration Prior Planned Caesarean Section | ||
正式标题 ICMJE | Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial | ||
简要概况 | Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. Infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes. Objectives:1) To reduce neonatal respiratory morbidity and admission to the Neonatal Intensive Care Unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery. 2) To collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator. Study design: Open label; randomised, placebo controlled trail Intervention: Oxytocin challenge test (OCT): Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped. Primary endpoint: - Incidence of neonatal respiratory morbidity Secondary endpoints: - Umbilical cord blood copeptin levels - Postnatal neonatal weight change - Breastfeeding status |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
1450 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | December 31, 2022 | ||
预计主要完成日期 | June 30, 2022 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Singleton pregnancy >34 weeks - primary caesarean section, that is without preceding contractions or rupture of the membranes, - absence of a contraindication to oxytocin Exclusion Criteria: - Chromosomal aberration - malformation, - IUGR, - Nonreassuring fetal heart rate pattern, - Placenta praevia, - maternal substance abuse, - infections, - hypertension, - preeclampsia, - diabetes type I or II, - autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.), - renal disease, - history of more than one previous caesarean section. | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Switzerland | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | University of Zurich | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |