Qualitative human chorionicgonadotropin testing of cervicovaginal washings for the detection of preterm premature rupture of membranes

doi:10.1016/j.ajog.2004.06.076

American Journal of Obstetrics and Gynecology

Volume 191, Issue 2, August 2004, Pages 593-596

https://doi.org/10.1016/j.ajog.2004.06.076 Get rights and content

Objective

This study was performed to determine whether a qualitative human chorionicgonadotropin (hCG) test using cervicovaginal washings obtained from pregnant women is a useful predictor of recent preterm premature rupture of the membranes (PPROM).

Study design

A prospective observational analysis of qualitative hCG testing on cervicovaginal washings in patients with either known PPROM or with intact membranes was performed. Patients with singleton gestations between 24 and 34 completed weeks were included. PPROM patients had documented comfirmatory tests, including visualized pooling of amniotic fluid in the vaginal vault that was nitrazine-positive and demonstrated ferning. Those with vaginal bleeding or an anomalous fetus were excluded. Before collection, all patients were screened for bacterial vaginosis and trichomoniasis. Washings were then collected from the posterior vaginal fornix with the use of a 5-mL sterile saline irrigation and aspiration technique. Samples were then agitated manually and applied to the Quickvue Onestep qualitative pregnancy test (Quidell, San Diego, Calif) with a threshold of 25 mIU/mL. Data were analyzed with the t test, χ², and Fischer exact tests. Sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values were calculated. When applicable, all 2-tailed P < .05 were considered significant.

Results

Fifty-two patients were enrolled in the study with 24 in the PPROM group and 28 in the control group. The 2 groups were similar with respect to demographic characteristics and wet preparation results. The mean gestation age was 31.4 ± 2.4 (X ± SD) and 30.8 ± 2.7 weeks in the PPROM and control groups, respectively. The hCG test was positive in 19 (79%) of the PPROM patients and in 1 (3.6%) of the controls (sensitivity 79%, specificity 96%, PPV 95%, NPV 84%).

Conclusion

Qualitative hCG testing of cervicovaginal washings appears to be an useful predictor of PPROM.

Section snippets

Material and methods

A prospective observational analysis of pregnant women between 24 and 34 6/7 weeks gestation was conducted between February 2002 and April 2003. With the use of previously published data by other investigators evaluating quantitative hCG, a sample size of 50 patients was calculated to estimate 95% CI for the test's sensitivity of 0.80 ± 0.05. This Institutional Review Board-approved research was conducted by studying 2 naturally occurring patient groups. A convenience method of enrolling

Results

Fifty-two subjects were sampled with 24 in the PPROM group and 28 in the control group. Both groups were similar with respect to maternal age, racial makeup, and gestational age at the time of testing (Table I). Further, the PPROM group was sampled at median gestational age of 32 0/7 weeks ranging from 27 1/7 to 34 5/7 weeks and the control group median was 30 4/7 weeks ranging from 24 4/7 to 34 5/7 weeks. In the PPROM patients who were sampled, 19 of 24 had a positive hCG test resulting in a

Comment

In our study we were able to demonstrate an excellent PPV with reasonable sensitivity by using the qualitative hCG test on cervicovaginal washings in a sample of patients with the status of the membrane intactness known. These findings are promising as this simple and inexpensive test may be helpful in determining the presence of PPROM in equivocal cases. Equivocal traditional clinical testing is not uncommon and can be the result of factors such as the presence of vaginal infections, semen,

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Citation Excerpt :
Several tests, such as pooling, ferning, nitrazine, and AmniSure (QIAGEN), are available to confirm that pPROM has occurred. Despite the availability of a plethora of tests confirming its occurrence, there are no reliable markers or methods to predict pPROM before it occurs.44–47 Several reports have identified significant predisposing associations that increase the risk of pPROM, including reproductive tract infections, behavioral factors, environmental toxins, genetic factors, and obstetric complications.48–52
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Establecer la eficacia diagnóstica de la determinación de creatinina en flujo vaginal para el diagnóstico de la rotura prematura de membranas.
Se realizó una investigación de tipo prospectivo en una muestra de 270 embarazadas que asistieron al Hospital Central Dr. Urquinaona. Los grupos consistieron en pacientes con rotura prematura de membranas (grupo A: n = 135) y embarazadas con membranas íntegras (grupo B: n = 135), consideradas como controles. Se evaluaron las características generales, valores de creatinina en flujo vaginal y efectividad diagnóstica.
La edad gestacional al momento de la determinación de las concentraciones de creatinina en flujo vaginal fue de 32,9 ± 1,6 semanas para el grupo A y 33,1 ± 1,9 semanas para el grupo B (p = ns). No se encontraron diferencias estadísticamente significativas en la edad materna ni en la frecuencia de paridad entre ambos grupos de tratamiento (p = ns). Las pacientes del grupo A presentaron concentraciones significativamente más altas de creatinina en flujo vaginal (1,09 ± 0,35 mg/dl) comparadas con las embarazadas del grupo B (0,36 ± 0,17 mg/dl, p < 0,05). Un valor de corte de 0,45 mg/dl presentó un valor por debajo de la curva de 0,87 con una sensibilidad del 78,3%, especificidad del 78,7%, valor predictivo positivo del 80,6% y valor predictivo negativo del 76,4%.
La determinación de las concentraciones de creatinina en el flujo vaginal es una técnica diagnóstica útil para la rotura prematura de membranas.
To establish the diagnostic efficacy of determining creatinine concentrations in vaginal fluid for the diagnosis of premature rupture of membranes.
A prospective study was performed in a sample of 270 pregnant women attending the Dr. Urquinaona Central Hospital. Group A consisted of patients with premature rupture of membranes (n = 135) and group B of pregnant women with intact membranes (n = 135), considered as controls. We evaluated general characteristics, creatinine values in vaginal fluid, and diagnostic efficacy.
Gestational age at creatinine determination in vaginal fluid was 32.9 ± 1.6 weeks in group A and 33.1 ± 1.9 weeks in group B (p = ns). There were no significant differences in maternal age or the frequency of parity between the 2 groups (p = ns). Creatinine concentrations in vaginal fluid were significantly higher in group A (1.09 ± 0.35 mg/dl) than in group B (0.36 ± 0.17 mg/dl; P<.05). A cut-off point of 0.45 mg/dl showed an under the curve value of 0.87, with a sensitivity of 78.3%, a specificity of 78.7%, a positive predictive value of 80.6%, and a negative predictive value of 76.4%.
Determination of creatinine concentrations in vaginal fluid is a useful diagnostic tool for premature rupture of membranes.
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To detect the accuracy of the IGFBP-1 in diagnosing premature rupture of fetal membranes.
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In this study, the sensitivity and the specificity of IGFBP-1 (Actim PROM test®) in diagnosing PROM were 89.3% & 82.7%, respectively, as compared with 84% sensitivity & 78.7% specificity for Ferning test, and 86.7% sensitivity & 81.3% specificity for Nitrazine test. The PPV and NPV of IGFBP-1 (Actim PROM test®) were 83.8% & 88.6%, respectively, as compared with 79.7% PPV & 83.1% NPV for Ferning test, and 82.2% PPV & 85.9% NPV for Nitrazine test. The IGFBP-1 (Actim PROM test®) was more accurate (86%) for detection of PROM than Ferning (81.3%) or Nitrazine (84.0%) tests.
The Actim PROM test®, for detection of IGFBP-1 in the vaginal fluid is a simple bedside test, and can be used as complimentary test to confirm the clinical diagnosis of Premature rupture of fetal membranes.
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: John R. McCain Presentation, Presented at the Sixty-Sixth Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, Boca Raton, Florida, January 18-21, 2004.

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Transactions of the Annual Meeting of the South Atlantic Association of Obstetricians and GynecologistsQualitative human chorionicgonadotropin testing of cervicovaginal washings for the detection of preterm premature rupture of membranes

Objective

Study design

Results

Conclusion

Section snippets

Material and methods

Results

Comment

Am J Obstet Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Obstet Gynecol

Transactions of the Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists
Qualitative human chorionicgonadotropin testing of cervicovaginal washings for the detection of preterm premature rupture of membranes