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Neoventa公司推出STAN S21胎兒監(jiān)測系統(tǒng)

【?2005-01-25 發(fā)布?】 美迪醫(yī)訊
美迪網(wǎng)領(lǐng)先的醫(yī)療器械電子商務(wù)平臺

聯(lián)合使用ST段監(jiān)測以及標(biāo)準(zhǔn)胎兒心率監(jiān)測可以減少分娩時缺氧性腦損傷嬰兒數(shù)量以及不必要的剖腹產(chǎn)手術(shù)。

根據(jù)喬治亞醫(yī)學(xué)院研究人員的說法:單獨使用心率監(jiān)測能夠提供可怕的錯誤的安全感,該醫(yī)學(xué)院是研究聯(lián)合應(yīng)用心率監(jiān)測與ST段監(jiān)測項目的組長研究單位。被稱作STAN S21,這種胎兒心率監(jiān)測系統(tǒng)是由Neoventa醫(yī)療公司研制開發(fā)的,現(xiàn)在正在一項800例分娩的臨床實驗中接受檢測。先前在英國和瑞典的8000例分娩中的研究發(fā)現(xiàn),將血氣異常的嬰兒出生減少了50%,將不必要的剖腹產(chǎn)減少了20%;使用新系統(tǒng)監(jiān)測的嬰兒沒有出現(xiàn)腦缺氧性損傷。

喬治亞醫(yī)學(xué)院婦產(chǎn)科主任、教授、首席研究員Lawrence D.Devoe解釋說:“這是第一項實質(zhì)性的進步,將監(jiān)測水平提升到了新的水平,有助于增加監(jiān)測儀器的精確度,并幫助操作者獲得更好的臨床結(jié)論。”

研究該儀器的研究不是隨機的。在取得了家長知情同意書之后,該設(shè)備被用于妊娠至少36周的孕婦。胎兒是頭先露因此可以將電極放置于頭部而不是通過孕婦腹部來監(jiān)測心率。Devoe醫(yī)生指出這種分娩處于高危險之中。

他還說:“我們關(guān)注的是已經(jīng)接受測試的系統(tǒng)的可翻譯性并在其它國家進行證實。”

Fetal Monitoring That Reduces Brain Damage
 
Monitoring ST segment activity along with standard fetal heart rate during labor appears to reduce the number of babies born with hypoxic brain damage as well as unnecessary cesarean sections (C-sections).

Heart-rate monitoring alone can provide a horribly false sense of security, according to researchers at the Medical College of Georgia (Augusta, USA), the lead site for a study of a new system that combines heart monitoring with ST segment monitoring. Called STAN S21, the fetal heart monitor system was developed by Neoventa Medical (Molndal, Sweden) and is now being tested in a trial of some 800 labors. Prior studies during 8,000 labors in the United Kingdom and Sweden found a 50% reduction in babies born with abnormal blood gases, a 20% reduction in unnecessary C-sections, and no hypoxic brain damage in babies monitored with the new system.

“This is really the first practical breakthrough in moving the field of monitoring to the next level, that is helping the precision of the tool and helping people who use it to make better clinical decisions,” explained principal investigator Dr. Lawrence D. Devoe, professor and chair of the department of obstetrics and gynecology at the Medical College of Georgia.

The studies of the device are not randomized. With parental consent, the device is being used in pregnancies at least 36 weeks along, with the baby pointed head first and where there is enough concern to place an electrode on the head rather than monitor heart rate via the mother’s abdomen. Dr. Devoe classifies these labors at the “higher end of risk.”

“What we are looking at here is translatability of a system that has already been tested and proven in other countries,” he added.

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