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
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