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Prospective cohort study investigating the reliability of the AmnioSense™ method for detection of spontaneous rupture of membranes
Author(s) -
Mulhair L,
Carter J,
Poston L,
Seed P,
Briley A
Publication year - 2009
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2008.01828.x
Subject(s) - medicine , prospective cohort study , rupture of membranes , population , obstetrics , cohort , gestational age , gynecology , surgery , pregnancy , environmental health , biology , genetics
Objective 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). Design Prospective cohort study. Setting Antenatal Day Unit (ADU) of a UK inner‐city teaching hospital. Population Women attending the ADU with a history of suspected ruptured membranes between 18 and 42 weeks of gestation. Methods 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. Main outcome measures Comparability between the index test (AmnioSense™) and reference standard (speculum). Results 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). Conclusions 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.