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临床试验/EUCTR2015-001654-15-NL
EUCTR2015-001654-15-NL进行中(未招募)1 期

Intrauterine resuscitation during term labor by maternal hyperoxygenation. - INTEREST-O2

Máxima Medisch Centrum0 个研究点目标入组 50 人开始时间: 2015年8月25日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Maternal factors:
  • -Age > 18 years
  • -In term labor (gestational age 37+0 - 41+6 weeks)
  • -Intention for vaginal delivery
  • -Ability to understand the Dutch language
  • -Informed consent obtained
  • Fetal factors:
  • -Singleton fetus
  • -Fetus in head position
  • - Suspected fetal distress (Suboptimal or Abnormal CTG according to the FIGO guideline)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Maternal factors:
  • -Age < 18 years
  • -Use of any of the following medication: corticosteroids, antihypertensives, magnesiumsulphate, amiodaron, opioids, amiodaron, adriamycine, bleomycine, actinomycine, menadion, (chloor-) promazine, thiordiazine, chloroquine
  • -Pre-existing cardiac disease
  • -Pulmonary disease needing the use of medication
  • -Hyperthyroidism
  • -Anemia (Hb < 6.5 mmol/l)
  • -Smoking, using alcohol or recreational drugs during pregnancy
  • -Pre- or postterm labor (< 37+0 or > 41+6 weeks)
  • -Planned caesarean section
  • Fetal factors:
  • -Multiple fetuses
  • -Suspected growth restriction (-Suspected infection
  • -Congenital malformations
  • -Breech position

研究者

发起方
Máxima Medisch Centrum

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