Reproducibility and usability assessment of the novel Fine Birth device for threatened preterm labor diagnosis.

BACKGROUND: Preterm delivery is considered the leading cause of mortality worldwide in children under 5 years old. Approximately 45 million pregnant women are hospitalized yearly for threatened preterm labor. However, only 50% of pregnancies complicated by threatened preterm labor end in delivery before the estimated date, classifying the rest as false threatened preterm labor. The ability of current diagnostic methods to predict threatened preterm labor is low (low positive predictive value), ranging between 8% and 30%. This highlights the need for a solution that accurately detects and differentiates between false and real threatened preterm labors in women who attend obstetrical clinics and hospital emergency departments with delivery symptoms. OBJECTIVE: Primarily, this aimed to assess the reproducibility and usability of a novel medical device, the Fine Birth, aimed at accurately diagnosing threatened preterm labor through the objective quantification of pregnant women's cervical consistency. Secondarily, this study aimed to evaluate the effect of training and the incorporation of a lateral microcamera on the device's reliability and usability outcomes. STUDY DESIGN: A total of 77 singleton pregnant women were recruited during their follow-up visits to the obstetrical and gynecologic departments at 5 Spanish hospitals. The eligibility criteria included pregnant women aged ≥18 years; women with a normal fetus and uncomplicated pregnancy; women without prolapse of membranes, uterine anomalies, previous cervical surgery, or latex allergy; and women signing the informed written consent. Cervical tissue stiffness was assessed using the Fine Birth device, whose technology is based on the propagation of torsional waves through the studied tissue. Cervical consistency measurements were taken for each woman until obtaining 2 valid measurements by 2 different operators. The intraobserver and interobserver reproducibilities of the Fine Birth measurements were assessed using the intraclass correlation coefficients with a 95% confidence interval and the Fisher test P value. The usability was evaluated on the basis of the clinicians' and participants' feedback. RESULTS: There was good intraobserver reproducibility (intraclass correlation coefficient, 0.88; 95% confidence interval, 0.84-0.95; Fisher test P value<.05). As the results obtained for the interobserver reproducibility did not reach the desired acceptable values (intraclass correlation coefficient of <0.75), a lateral microcamera was added to the Fine Birth intravaginal probe, and the operators involved in the clinical investigation received the corresponding training with the modified device. The analysis of 16 additional subjects demonstrated excellent interobserver reproducibility (intraclass correlation coefficient, 0.93; 95% confidence interval, 0.78-0.97) and an improvement after the intervention (P<.0001). CONCLUSION: The robust reproducibility and usability results obtained after the insertion of a lateral microcamera and the corresponding training make the Fine Birth a promising novel device to objectively quantify the patient's cervical consistency, diagnose threatened preterm labor, and, thus, predict the risk of spontaneous preterm birth. Further research is needed to demonstrate the clinical utility of the device.

Use of the Robson Classification System to Assess Cesarean Delivery Rate in a Tertiary Hospital in the Basque Country.

OBJECTIVES: To assess the rate of cesarean delivery at Basurto University Hospital (Bilbao, Spain) between 2015 and 2017 and to determine the cause of an increase in this rate during 2017. METHODS: We retrospectively reviewed 6975 deliveries between 2015 and 2017, classifying women using the Robson classification. We analyzed extended perinatal mortality and perinatal outcomes during the study period and performed a comparative analysis of cesarean deliveries by year and Robson group. Comparisons were made with analysis of variance and χ2 or Fisher's exact tests. RESULTS: During the study period, 928 cesarean deliveries (13.3%) were performed. Extended perinatal mortality in this period was 7.0%. We detected an increase in the rate of cesarean delivery in 2017 in Group 1 women (P = 0.0224), with significant differences in the homogeneity of the distribution of cesarean deliveries performed for fetal distress between years in this group (P = 0.0093). Auditing the cases of cesareans performed for fetal distress in Group 1 in 2017, we found that the indication was appropriate in all cases, but in 39.4%, the management of uterine contractions during labour was considered suboptimal. CONCLUSION: Classifying cesarean deliveries using the Robson classification allows us to compare cesarean rates in different years and analyze any increases in these rates. Increases are sometimes attributed to changes in the obstetric population, but when investigated may be found to be related to potentially correctable problems. It is not necessary to have a high rate of cesarean delivery to warrant internal audit.