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Oxytocin Administration Prior Planned Caesarean Section

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合作者:
信息的提供 (责任方):
September 24, 2018
October 3, 2018
October 3, 2018
January 1, 2019
June 30, 2022   (主要结果测量的最终数据收集日期)
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

与当前相同
  • Umbilical cord blood copeptin levels[ Time Frame: blood sample within 30 minutes after birth ]
    copeptin levels in pmol/l
  • Postnatal neonatal weight change[ Time Frame: postnatal day 1-4 ]
    Maximum neonatal weight change in percent of birth weight
  • Breastfeeding status[ Time Frame: 1 year ]
    Percentage of children who are not, partially or full breastfed
 
Oxytocin Administration Prior Planned Caesarean Section
Mild Induced Labour Prior to Planned Caesarean Delivery to Improve Neonatal and Maternal Outcome - a Randomized Trial

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

Interventional
N/A
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
  • Other: 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.
  • Experimental: OCT-group
    Oxytocin challenge test: Oxytocin 5 IU/500 ml Ringer® lactate will be infused at a rate of 12 ml/h and doubled every 10 min until it induced three uterine contractions per 10-min interval at which point it will stopped.
  • No Intervention: Control
    standard procedure before planned caesarean section
 
Not yet recruiting
1450
与当前相同
December 31, 2022
June 30, 2022   (主要结果测量的最终数据收集日期)
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.
参与研究的性别: Female
最小年龄:18 Years ,最大年龄:N/A  
没有
Switzerland
 
Yes
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
计划分享 IPD: No
University of Zurich
Principal Investigator: Tilo Burkhardt, MD Dept. of Obstetrics, University Hospital Zurich
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
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