Mulhair L, Carter J, Poston L, Seed P, Briley A
Women's Health Department, Guy's and St Thomas' NHS Foundation Trust, London, UK.
BJOG. 2009 Jan;116(2):313-8. doi: 10.1111/j.1471-0528.2008.01828.x. Epub 2008 Jul 23.
This study investigated the reliability, sensitivity and specificity of a commercially available absorbent pad, AmnioSense, compared with speculum examination for detection of spontaneous ruptured membranes (SRM).
Prospective cohort study.
Antenatal Day Unit (ADU) of a UK inner-city teaching hospital.
Women attending the ADU with a history of suspected ruptured membranes between 18 and 42 weeks of gestation.
Eligible women were asked to use the absorbent pad in accordance with the manufacturer's instructions. A midwife recorded the result. A second midwife performed a speculum examination according to unit protocol. Results were entered onto a password-protected study-specific database. Both midwives were blind to the other test result.
Comparability between the index test (AmnioSense) and reference standard (speculum).
A total of 157 women were recruited and results were analysed in 139 cases. Median gestational age at recruitment was 37(+2) weeks. The prevalence of SRM was 42% (59/139) with AmnioSense giving a sensitivity of 98% (58/59) and specificity of 65% (52/80).
Thirty-eight percent (53/139 women) with SRM would have been correctly identified as having intact membranes without the need for a speculum examination. Twenty-five percent of AmnioSense false-positive results were associated with positive high vaginal swab results (7/28). These data suggest that a negative AmnioSense result can provide reassurance of intact membranes. Use of the AmnioSense test before considering speculum examination could reduce the number of speculum examinations undertaken, with benefit to women and concomitant health resource savings.
本研究调查了一种市售吸收垫AmnioSense与窥器检查相比，用于检测胎膜早破（SRM）的可靠性、敏感性和特异性。
前瞻性队列研究。
英国市中心一家教学医院的产前日间病房（ADU）。
妊娠18至42周因疑似胎膜破裂病史而到ADU就诊的女性。
符合条件的女性被要求按照制造商的说明使用吸收垫。一名助产士记录结果。另一名助产士根据科室规程进行窥器检查。结果录入受密码保护的特定研究数据库。两名助产士均对另一个检测结果不知情。
指标检测（AmnioSense）与参考标准（窥器检查）之间的可比性。
共招募了157名女性，对139例的结果进行了分析。招募时的中位孕周为37（+2）周。AmnioSense检测到的SRM患病率为42%（59/139），敏感性为98%（58/59），特异性为65%（52/80）。
38%（53/139名女性）的胎膜早破患者无需进行窥器检查就能被正确判定为胎膜完整。AmnioSense 25%的假阳性结果与高阴道拭子阳性结果相关（7/28）。这些数据表明，AmnioSense检测结果为阴性可使人放心胎膜完整。在考虑进行窥器检查之前使用AmnioSense检测可减少窥器检查的次数，对女性有益并能节省相应的医疗资源。
