Observational study - Monitoring contractions during labor: comparing real-time electrohysterography to external and internal tocodynamometry - W3-study

Maxima Medisch Centrum0 个研究点目标入组 131 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•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.

•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 known positive GBS (Group B Streptococcus)-status in the urine or vagina, and women with a positive hepatitis B, hepatitis 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, 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.

发起方

Maxima Medisch Centrum