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临床试验/NL-OMON23485
NL-OMON23485已完成不适用

Monitoring contractions during labor: comparing real-time electrohysterography to internal and external tocodynamometry.

Board of Management Máxima Medical Center, Veldhoven, the Netherlands0 个研究点目标入组 131 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
131

研究概览

简要总结

ot yet

研究设计

研究类型
Observational

入排标准

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria: women with a singleton pregnancy and gestational age between 37 and 42 weeks, in active labor with a fetus in cephalic presentation, ruptured membranes and fetal scalp electrode. We will apply strict criteria regarding diagnosis of labor: a pregnant woman needs to have regular painful contractions at least three each ten minutes, and a fully effaced cervix with minimum 3 centimeters of dilation.

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study: women under the age of 18 years old, women with a multiple pregnancy, women with signs of fetal distress (abnormal CTG requiring immediate intervention), women with a positive Group B streptococcus status in urine or vagina, and women with a positive hepatitis B/C or HIV serology. Contraindications to IUPC placement are uterine bleeding of undetermined origin, a suspected placenta praevia, vasa praevia, and signs of intrauterine infection (maternal fever >38C with fetal tachycardia >160 beats per minute). Contraindications to EHG placement are dermatologic diseases of the abdomen precluding preparation of the abdomen with abrasive paper, women in labor taking a shower or bath and women connected to external or implanted electrical stimulators.

研究者

发起方
Board of Management Máxima Medical Center, Veldhoven, the Netherlands

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