Cell-free DNA test for fetal chromosomal abnormalities in multiple pregnancies.

INTRODUCTION: This study aimed to report the screening performance of cell-free DNA (cfDNA) testing for chromosomal abnormalities in twins, triplets, and vanishing twin pregnancies. MATERIAL AND METHODS: Data were obtained from pregnant women with a multiple pregnancy or a vanishing twin pregnancy at ≥10 weeks' gestation who requested self-financed cfDNA testing between May 2015 and December 2021. Those that had positive screening results had diagnostic confirmatory procedures after counseling and consent. The performance of screening of the cfDNA test was determined by calculating confirmation rate and combined false-positive rate (cFPR). RESULTS: Data from 292 women were included after exclusion of those lost to follow-up, with no-result on cfDNA testing, or had reductions. Of the 292 pregnancies, 10 (3.4%) were triplets, including no cases of trisomy 21 and trisomy 18; 249 (85.3%) were twins, including 3 cases of trisomy 21 and no cases of trisomy 18 and 13; and 33 (11.3%) were vanishing twins, including 3 cases of trisomy 21 and 1 case of trisomy 18. The median (IQR) maternal age was 34 years (31-37). For triplet pregnancies, the initial no-result rate was 10.3% (95% confidence interval [CI] 3.6-26.4), all with results after redraw. For twin pregnancies, the initial no-result rate was 12.9% (95% CI 9.6-17.0), and the no-result rate after redraw was 1.6% (95% CI 0.7-3.6). For vanishing twins, there were no cases with no-result. All triplets had low-risk cfDNA results. The confirmation rate for trisomy 21 was 100% with a FPR at 0% due to the small number of positive cases for twins. For vanishing twins, one high-risk case for trisomy 21 and the only high-risk case for trisomy 18 were confirmed with a cFPR of 8.3% (n = 2/24; 95% CI 2.3-25.9). CONCLUSIONS: cfDNA testing in twin pregnancies has sufficient screening performance for trisomy 21 but the number of affected cases for other conditions is limited to draw any meaningful conclusion. The use of cfDNA testing in triplet pregnancies and vanishing twins remains an area for further research.

Influence on operative time of immediate skin-to-skin care in low-risk primary cesarean births for breech presentation: Retrospective cohort study.

BACKGROUND: Multiple benefits for both, mother and baby have been reported from immediate skin-to-skin care (SSC). The aim of this study was to analyze the influence of SSC on operative time and blood loss in primary cesarean births for breech presentation. METHODS: A SSC protocol for cesarean birth was implemented in our institution on February 25, 2019. In this single-center retrospective cohort study, we compared the outcomes of planned primary cesarean births for breech presentation at term before and after its implementation. RESULTS: Data from 110 women who had a cesarean birth for breech presentation at term were analyzed, 55 in each group. Group 1 were women who had immediate SSC and Group 2 were women without immediate SSC. Maternal and surgical characteristics, and neonatal outcomes were similar in both groups. The mean operative time was 3.22 minutes shorter in the immediate SSC group compared with the not immediate SSC group (37.13 ± 12.27 vs 40.35 ± 12.23 minutes; P = 0.171). CONCLUSIONS: In conclusion, immediate SSC following a low-risk cesarean birth for breech presentation neither prolongs the operative time nor increases blood loss during the procedure. Although we were unable to demonstrate a significant reduction in the operative time with the immediate SSC protocol, a decrease of 3 minutes was noted.

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.

Multisite assessment of the impact of a prenatal testing educational App on patient knowledge and preparedness for prenatal testing decision making.

In this study, we wanted to assess the impact of the use of a patient educational app on patient knowledge about noninvasive prenatal testing (NIPT) and preparedness for prenatal screening decision-making. A randomized control study was carried out at three international sites between January 2019 and October 2020. Study participants completed a pre-consultation survey and post-consultation survey to assess knowledge, satisfaction, and preparedness for prenatal screening consultation. Providers completed a post-consultation survey. In the control arm, the pre-consultation survey was completed prior to consultation with their prenatal care provider. In the intervention arm, the pre-consultation survey was completed after using the app but prior to consultation with their prenatal care provider. Mean knowledge scores in the 203 participants using the app were significantly higher pre-consultation (p < 0.001) and post-consultation (p < 0.005) than those not using the app. Higher pre-consultation knowledge scores in the intervention group were observed at all sites. Most (86%) app users stated they were "Satisfied" or "Very Satisfied" with it as a tool. Providers rated the intervention group as more prepared than controls (p = 0.027); provider assessment of knowledge was not significantly different (p = 0.073). This study shows that clinical implementation of a patient educational app in a real-world setting was feasible, acceptable to pregnant people, and positively impacted patient knowledge.