Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor

A Rapid Amniotic Fluid Interleukin-6 Assessment for the Identification of Intra-Amniotic Inflammation in Women with Preterm Labor and Intact Membranes

“…The interclass correlation coefficient and Passing-Bablok regression [13] analyses were calculated to measure agreement between the 2 methods. The diagnostic performance of AF IL-6 alone and included in a multivari-able predictive model (including GA at admission, cervical length measurement, AF glucose, and IL-6 in a log scale) [2] Multivariable analysis was performed by backward stepwise logistic regression using the LR method. The regression formula for spontaneous delivery within 7 days was −7.588 + 0.132*GA at admission −0.051*US cervical length -0.055* AF glucose +1.432* AF log (IL-6) [2].…”

“…Microbial invasion of the amniotic cavity (MIAC) and intra-amniotic inflammation are involved in the etiology of early spontaneous preterm delivery (sPTD) [1,2]. Thus, earlier onset of symptoms, earlier gestational age (GA) at delivery, and a shorter latency to delivery have been widely reported in women with MIAC and/or intraamniotic inflammation admitted with symptoms of preterm labor (PTL) and intact membranes [1,3,4].…”

“…Our group recently developed and validated a multivariable predictive model of sPTD within 7 days in women with PTL that included clinical variables such as GA, ultrasound (US) cervical length measurement, and amniotic fluid (AF) glucose and interleukin (IL)-6 concentrations [2]. However, IL-6 was measured using the ELISA method, thereby limiting clinical translation.…”

“…However, these immunoassays have not been validated as a method to measure AF IL-6 in women with PTL. Since instrument validation is important in laboratory work before clinical implementation of a new method, the objectives of this study were to validate an automated immunoassay as a quantitative method to measure AF IL-6 in women with PTL and to evaluate the diagnostic performance of AF IL-6 alone and as part of a predictive model of sPTD within 7 days [2] with this automated method.…”

“…In brief as reported previously [2], standard management of women diagnosed with PTL included US transvaginal cervical length measurement and maternal blood analysis for evaluation of maternal C-reactive protein and white blood cell count at admission. As part of the institutional clinical protocols, women with singleton pregnancies admitted with a diagnosis of PTL below 34 weeks were offered amniocentesis to rule out MIAC.…”