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.

Doppler assessment of patients with twin-to-twin transfusion syndrome and survival following fetoscopic laser surgery.

OBJECTIVE: To investigate fetal-survival rates following laser surgery for twin-to-twin transfusion syndrome (TTTS) and the impact of Doppler analysis. METHODS: The present retrospective single-center study included data from patients with pregnancies exhibiting TTTS treated with fetoscopic laser surgery between January 1, 2007, and December 31, 2016. Perinatal outcomes were examined and variables were compared between the donor and recipient fetuses that survived and died, respectively. RESULTS: There were 86 pregnancies exhibiting TTTS treated with fetoscopic laser surgery included in the study. The median length of pregnancy at the time of surgery was 21.1 weeks. Both twin fetuses and at least one fetus survived in 61 (71%) and 73 (85%) pregnancies, respectively. Among recipient fetuses, ductus venosus a-wave anomalies (P=0.026), shorter cervical length (P=0.044), and a greater than 25% discrepancy in the estimated weight of the twin fetuses (P=0.045) were associated with reduced survival. CONCLUSION: Among pregnancies exhibiting TTTS, laser surgery was associated with significant dual-fetus survival. Preoperative ductus venosus anomalies were associated with lower survival among recipient fetuses, and 1-week postsurgical ultrasonography data demonstrated lower survival among recipient fetuses with persistent anomalous ductus venosus compared with normalized ductus venosus.

Nasal bone assessment in fetuses with trisomy 21 at 16-24 weeks of gestation by three-dimensional ultrasound.

OBJECTIVE: This study aims to investigate the length and shape of the nasal bones in fetuses with trisomy 21 at 16-24 weeks' gestation. METHOD: We acquired three-dimensional volumes of the fetal profile from 41 fetuses with trisomy 21. The multiplanar mode was used to measure nasal bone length in the exact midsagittal plane and in parasagittal and oblique views of the fetal face and to examine the nasal bones in the coronal plane. RESULTS: There was bilateral absence of the nasal bones in 11 (26.8%) cases and unilateral absence in one (2.4%). In 29 (70.7%) cases with present nasal bones, there was progressive over-estimation of nasal bone length when measured in parasagittal and oblique views compared to measurements taken in the exact midsagittal plane. In the coronal plane, in 18 of 29 (62.1%) fetuses with trisomy 21, the nasal bones were divergent, whereas in 131 of 135 (97.0%) euploid fetuses, the bones were entirely fused in the midline. CONCLUSION: Parasagittal and oblique scanning planes may produce over-estimation of nasal bone length in trisomy 21 fetuses because they often have divergent nasal bones. Consequently, it is essential that measurement of nasal bone length is carried out in the exact midsagittal plane of the face.