腹电式动态胎儿监护仪的临床应用研究  

Clinical trial of abdominal electrodynamic fetal monitor

作　　者：许琦[1] 王楠[2] 邢丽莉[1] 倪胜莲[2] 刘国莉[1] 王妍[2] XU Qi;WANG Nan;XING Lili;NI Shenglian;LIU Guoli;WANG Yan(Gynecology and obstetrics,Peking University People's Hospital,Peking,100044,China;Gynecology and obstetrics,Peking University Third Hospital,Peking,100191,China)

机构地区：[1]北京大学人民医院妇产科,北京100044 [2]北京大学第三医院妇产科,北京100191

出　　处：《中国妇产科临床杂志》2023年第6期605-608,共4页Chinese Journal of Clinical Obstetrics and Gynecology

基　　金：国家重点研发计划基金资助项目(2019YFC0119704)。

摘　　要：目的评价腹电式动态胎儿监护仪的有效性和安全性。方法于2022年9月至2022年12月在北京大学第三医院和北京大学人民医院招募130例妊娠晚期孕妇,采用腹电式动态胎儿监护仪和传统胎心监护仪分别进行监护,比较两组胎心数据一致性、胎心监护图形临床判读结果符合率、宫缩信号的一致性、母体心率一致性数据点,以及腹电式动态胎儿监护仪与多普勒胎儿监护仪的一致性、连续性及完整性。结果130例孕妇中,因器械缺陷等因素剔除15例(11.54%,15/130)。129例全分析集(full analysis set,FAS)中,平均胎心数据一致性占比为95.18%(95%CI:94.21%~96.15%);符合方案集(per protocol set,PPS)中,平均胎心数据一致性占比为95.15%(95%CI:94.18%~96.12%)。FAS和PPS中,胎心监护图形判读符合率的平均值分别为78.26%和78.76%(95%CI:70.29%~86.23%;70.78%~86.74%);两种监护仪器械平均宫缩信号的一致性分别为80.00%vs 80.00%(95%CI:74%~87%;73%~87%);母体心率一致性占比平均分别为98.46%和98.45%(95%CI为96.73%~100.18%;96.71%~100.19%)。使用设备(3±1)d内患者无局部皮肤皮损或过敏反应等不良事件。结论与传统的多普勒胎儿监护仪比较,腹电式动态胎儿监护仪有效性高,安全可靠,可实现24 h长时间胎儿监护,可以有效判断胎儿宫内情况。Objective To evaluate the effectiveness and safety of abdominal electric dynamic fetal monitor.Methods From September 2022 to December 2022,130 pregnant women in the third trimester of pregnancy were recruited from Peking University Third Hospital and Peking University People's Hospital,and the data were collected by abdominal electric dynamic fetal monitor and traditional fetal heart monitor respectively.The consistency,continuity and integrity of the dynamic fetal monitor and Doppler fetal monitor were compared by comparing the consistency ratio of fetal heart data,the consistency rate of fetal heart monitor graphic clinical interpretation results,the consistency of uterine contraction signal and the consistency percentage of maternal heart rate data points between two groups.Results Among 130 pregnant women,15 cases(11.54%,15/130)were excluded due to factors such as device defects.In the full analysis set(FAS),the consistency ratio(%)of fetal heart data was 95.18%(95%CI:94.21%~96.15%).In the per protocol set(PPS),the consistency rate of fetal heart data was 95.15%on average(95%CI:94.18%~96.12%).In FAS and PPS,the mean interpretation coincidence rates of fetal heart monitoring patterns were 78.26%vs 78.76%(95%CI:70.29%~86.23%vs 70.78%~86.74%),respectively.The average consistency(%)of the contraction signals collected by the two monitoring instruments was 80%vs 80%(95%CI 74%to 87%vs 73%to 87%).The mean maternal heart rate consistency ratio(%)was 98.46%vs 98.45%(95%CI 96.73%~100.18%vs 96.71%~100.19%).No adverse events such as local skin lesions or allergic reactions occurred within 3±1 days after use of the device.Conclusion Compared with the traditional Doppler fetal monitor,the dynamic fetal monitor with abdominal electrodynamic fetal monitor is more effective,safe and reliable,and can realize the long-term fetal monitoring for 24 hours,and can judge the fetal situation more accurately and effectively.

关 键 词：胎心检测 胎儿心电图 胎儿电子监护 胎儿心率 形态学分析 

分 类 号：R714.5[医药卫生—妇产科学]