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The potential benefits and limitations of benign hysterectomy surgical approaches are still debated. We aimed at evaluating any differences with a systematic review and meta-analysis. PubMed, MEDLINE, and EMBASE databases were last searched on 6/2/2021 to identify English randomized controlled trials (RCTs), prospective cohort and retrospective independent database studies published between Jan 1, 2010 and Dec 31, 2020 reporting perioperative outcomes following robotic hysterectomy versus laparoscopic, open, or vaginal approach (PROSPERO #CRD42022352718). Twenty-four articles were included that reported on 110,306 robotic, 262,715 laparoscopic, 189,237 vaginal, and 554,407 open patients. The robotic approach was associated with a shorter hospital stay (p < 0.00001), less blood loss (p = 0.009), and fewer complications (OR: 0.42 [0.27, 0.66], p = 0.0001) when compared to the open approach. The main benefit compared to the laparoscopic and vaginal approaches was a shorter hospital (R/L WMD: - 0.144 [- 0.21, - 0.08], p < 0.0001; R/V WMD: - 0.39 [- 0.70, - 0.08], p = 0.01). Other benefits seen were sensitive to the inclusion of database studies. Study type differences in outcomes, a lack of RCTs for robotic vs. open comparisons, learning curve issues, and limited robotic vs. vaginal publications are limitations. While the robotic approach was mainly comparable to the laparoscopic approach, this meta-analysis confirms the classic benefits of minimally invasive surgery when comparing robotic hysterectomy to open surgery. We also reported the advantages of robotic surgery over vaginal surgery in a patient population with a higher incidence of large uterus and prior surgery., (© 2023. The Author(s).)

Purpose: As part of the wide adoption of minimally invasive surgery, intracorporeal anastomosis is becoming increasingly common. The benefits of minimally invasive versus open right colectomy are well known although the additional benefits of an intracorporeal anastomosis, performed laparoscopically or robotically, are unclear. The aim of this study was to assess the current literature comparing intracorporeal and extracorporeal anastomosis in the setting of laparoscopic and robotic-assisted right colectomy., Methods: A systematic review and meta-analysis was conducted according to PRISMA and AMSTAR methods. Studies included were randomized controlled trials and prospective or retrospective cohort studies, between January 1 2010 and July 1 2021, comparing intracorporeal and extracorporeal anastomosis with laparoscopic and robotic approaches. Four groups were identified: laparoscopic extracorporeal anastomosis (L-ECA), laparoscopic intracorporeal anastomosis (L-ICA), robotic extracorporeal anastomosis (R-ECA), and robotic intracorporeal anastomosis (R-ICA). Operative time, rate of conversion to an open procedure, surgical site infection, reoperation within 30 days, postoperative complications within 30 days, and length of hospital stay were assessed., Results: Twenty-one retrospective cohort studies were included in the final analysis. R-ICA and R-ECA had comparable operative times, but a robotic approach required more time than laparoscopic (68 min longer, p < 0.00001). Conversion to open surgery was 55% less likely in the R-ICA group vs. L-ICA, and up to 94% less likely in the R-ICA group in comparison to the R-ECA group. Length of hospital stay was shorter for R-ICA by a half day vs. R-ECA, and up to 1 day less vs. L-ECA. There were no differences in postoperative complications, reoperations, or surgical site infections, regardless of approach. However, the included studies all had high risks of bias due to confounding variables and patient selection., Conclusion: Robotic-assisted right colectomy with intracorporeal anastomosis was associated with shorter length of hospitalization and decreased rate of conversion to open surgery, compared to either laparoscopic or extracorporeal robotic approaches. Prospective studies are needed to better understand the true impact of robotic approach and intracorporeal anastomosis in right colectomy., (© 2023. Springer Nature Switzerland AG.)

Objective: To assess long-term outcomes with robotic versus laparoscopic/thoracoscopic and open surgery for colorectal, urologic, endometrial, cervical, and thoracic cancers., Background: Minimally invasive surgery provides perioperative benefits and similar oncological outcomes compared with open surgery. Recent robotic surgery data have questioned long-term benefits., Methods: A systematic review and meta-analysis of cancer outcomes based on surgical approach was conducted based on Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines using Pubmed, Scopus, and Embase. Hazard ratios for recurrence, disease-free survival (DFS), and overall survival (OS) were extracted/estimated using a hierarchical decision tree and pooled in RevMan 5.4 using inverse-variance fixed-effect (heterogeneity nonsignificant) or random effect models., Results: Of 31,204 references, 199 were included (7 randomized, 23 database, 15 prospective, 154 retrospective studies)-157,876 robotic, 68,007 laparoscopic/thoracoscopic, and 234,649 open cases. Cervical cancer: OS and DFS were similar between robotic and laparoscopic [1.01 (0.56, 1.80), P =0.98] or open [1.18 (0.99, 1.41), P =0.06] surgery; 2 papers reported less recurrence with open surgery [2.30 (1.32, 4.01), P =0.003]. Endometrial cancer: the only significant result favored robotic over open surgery [OS; 0.77 (0.71, 0.83), P <0.001]. Lobectomy: DFS favored robotic over thoracoscopic surgery [0.74 (0.59, 0.93), P =0.009]; OS favored robotic over open surgery [0.93 (0.87, 1.00), P =0.04]. Prostatectomy: recurrence was less with robotic versus laparoscopic surgery [0.77 (0.68, 0.87), P <0.0001]; OS favored robotic over open surgery [0.78 (0.72, 0.85), P <0.0001]. Low-anterior resection: OS significantly favored robotic over laparoscopic [0.76 (0.63, 0.91), P =0.004] and open surgery [0.83 (0.74, 0.93), P =0.001]., Conclusions: Long-term outcomes were similar for robotic versus laparoscopic/thoracoscopic and open surgery, with no safety signal or indication requiring further research (PROSPERO Reg#CRD42021240519)., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Higher capital costs and operating room costs associated with Lobectomy via Robot Assisted Thoracic Surgery (RATS) have previously been suggested as the principal contributors to the elevated overall cost. This study uses a micro-costing approach to a previous analysis of clinical outcomes of RATS, Video-Assisted Thoracic Surgery (VATS) and Open Lobectomy to evaluate the most significant cost drivers for the higher cost of robot-assisted lobectomy. A micro-costing model was developed to reflect the pathway of patients from day of surgery through the first 30 days following lobectomy. Costs were provided for RATS, VATS and Open approaches. Sensitivity analysis was performed specifically in the area of staff costs. A threshold sensitivity analysis of the overall cost components was also performed. Total cost per case for the RATS approach was €13,321 for the VATS approach €11,567, and for the Open approach €12,582. The overall cost differences were driven primarily by the elevated consumable costs associated with RATS Lobectomy. Capital costs account for a relatively small proportion of the per-case cost difference. This study presents a detailed analysis of the cost drivers for lobectomy, modelled for the three primary surgical approaches. We believe this is a useful tool for surgeons, hospital management, and service commissioning agencies to accurately and comprehensively determine where cost savings can be applied in their programme to improve the cost-effectiveness of RATS lobectomy., (© 2022. The Author(s).)

Importance: The cost-effectiveness of different surgical techniques for radical prostatectomy remains a subject of debate. Emergence of recent critical clinical data and changes in surgical equipment costs due to their shared use by different clinical specialties necessitate an updated cost-effectiveness analysis in a centralized, largely government-funded health care system such as the UK National Health Service (NHS)., Objective: To compare robotic-assisted radical prostatectomy (RARP) with open radical prostatectomy (ORP) and laparoscopic-assisted radical prostatectomy (LRP) using contemporary data on clinical outcomes, costs, and surgical volumes in the UK., Design, Setting, and Participants: This economic analysis used a Markov model developed to compare the cost-effectiveness of RARP, LRP, and ORP to treat localized prostate cancer. The model was constructed from the perspective of the UK NHS. The model simulated 65-year-old men who underwent radical prostatectomy for localized prostate cancer and were followed up for a 10-year period. Data were analyzed from May 1, 2020, to July 31, 2021., Exposures: Robotic-assisted radical prostatectomy, LRP, and ORP., Main Outcomes and Measures: Quality-adjusted life-years (QALYs), costs (direct medical costs and costs outside the NHS), and incremental cost-effectiveness ratios (ICERs)., Results: Compared with LRP, RARP cost £1785 (US $2350) less and had 0.24 more QALYs gained; thus, RARP was a dominant option compared with LRP. Compared with ORP, RARP had 0.12 more QALYs gained but cost £526 (US $693) more during the 10-year time frame, resulting in an ICER of £4293 (US $5653)/QALY. Because the ICER was below the £30 000 (US $39 503) willingness-to-pay threshold, RARP was more cost-effective than ORP in the UK. The most sensitive variable influencing the cost-effectiveness of RARP was the lower risk of biochemical recurrence (BCR). Scenario analysis indicated RARP would remain more cost-effective than ORP as long as the BCR hazard ratios comparing RARP vs ORP were less than 0.99., Conclusions and Relevance: These findings suggest that in the UK, RARP has an ICER lower than the willingness-to-pay threshold and thus is likely a cost-effective surgical treatment option for patients with localized prostate cancer compared with ORP and LRP. The results were mainly driven by the lower risk of BCR for RARP. These findings may differ in other health care settings where different thresholds and costs may apply.

Survival analysis following oncological treatments require specific analysis techniques to account for data considerations, such as failure to observe the time of event, patient withdrawal, loss to follow-up, and differential follow up. These techniques can include Kaplan-Meier and Cox proportional hazard analyses. However, studies do not always report overall survival (OS), disease-free survival (DFS), or cancer recurrence using hazard ratios, making the synthesis of such oncologic outcomes difficult. We propose a hierarchical utilization of methods to extract or estimate the hazard ratio to standardize time-to-event outcomes so that study inclusion into meta-analyses can be maximized. We also provide proof-of concept results from a statistical analysis that compares OS, DFS, and cancer recurrence for robotic surgery to open and non-robotic minimally invasive surgery. In our example, use of the proposed methodology would allow for the increase in data inclusion from 108 hazard ratios reported to 240 hazard ratios reported or estimated, resulting in an increase of 122%. While there are publications summarizing the motivation for these analyses, and comprehensive papers describing strategies to obtain estimates from published time-dependent analyses, we are not aware of a manuscript that describes a prospective framework for an analysis of this scale focusing on the inclusion of a maximum number of publications reporting on long-term oncologic outcomes incorporating various presentations of statistical data., Competing Interests: “All authors are employees of Intuitive Surgical, Inc. (AEH, USK, AY, DG, YLi, SL, YLiu) or consult for Intuitive Surgical, Inc. (ABS, SM, AES). There are no patents, products in development or marketed products to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”

Objectives: A number of meta-analytical and database studies have sought to compare open, video-assisted thoracoscopic surgery (VATS) and robotic operative approaches to lobectomy, often with conflicting results. Our objective was to perform a comprehensive review of these meta-analytical and database studies published to date., Methods: A systematic review was conducted in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines using the PubMed and Scopus databases. Primary outcome was short-term mortality, and secondary outcomes were operative time, blood loss or transfusion rate, hospital stay, conversions, lymph node yield and complications. Meta-analyses of the primary and secondary outcomes were performed., Results: Robotic lobectomy is a valid alternative to the VATS approach and is superior to the open approach with respect to complications [OR 0.67, 95% CI 0.58-0.76, P  < 0.00001] and duration of hospital stay (WMD -1.4, 95% CI -1.96-0.85, P < 0.00001). It is inferior to both VATS and open with respect to operative duration (robotic vs. VATS; WMD 4.98, 95% CI 2.61-7.36, P < 0.001, robotic vs. open WMD 65.56, 95% CI 53.66-77.46, P < 0.00001). Robotic approach is superior with respect to 30-day mortality compared to VATS (OR 0.61, 95% CI 0.45-0.83, P = 0.001 and open approaches (OR 0.53, 95% CI 0.33-0.85, P = 0.008)., Conclusions: This is the largest published systematic review and meta-analysis to date qualifying the robotic lobectomy as a reasonable alternative to VATS and open surgery. Short-term survival is superior in the robotic cohorts. No definitive conclusions on long-term outcomes can be drawn until a randomized controlled trial comparing approaches is conducted., (© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Median sternotomy has been the most commonly used approach for thymectomy to date. Recent advances in video-assisted thoracoscopic surgery (VATS) and robotic access with CO 2 insufflation techniques have allowed more minimally invasive approaches. However, prior reviews have not compared robotic to both open and VATS thymectomy., Methods: A systematic review was conducted in accordance with the PRISMA guidelines using PubMed, Embase and Scopus databases. Original research articles comparing robotic to VATS or to open thymectomy for myasthenia gravis, anterior mediastinal masses, or thymomas were included. Meta-analyses were performed for mortality, operative time, blood loss, transfusions, length of stay, conversion to open, intraoperative and postoperative complication rates, and positive/negative margin rates., Results: Robotic thymectomy is a valid alternative to the open approach; advantages include: reduced blood loss [weighted mean difference (WMD): -173.03, 95% confidence interval (95% CI): -305.90, -40.17, P=0.01], fewer postoperative complications (odds ratio: 0.37, 95% CI: 0.22, 0.60, P<0.00001), a shorter hospital stay (WMD: -2.78, 95% CI: -3.22, -2.33, P<0.00001), and a lower positive margin rate (relative difference: -0.04, 95% CI: -0.07, -0.01, P=0.01), with comparable operative times (WMD: 6.73, 95% CI: -21.20, 34.66, P=0.64). Robotic thymectomy was comparable with the VATS approach; both have the advantage of avoiding median sternotomy., Conclusions: While randomized controlled studies are required to make definitive conclusions, current data suggests that robotic thymectomy is superior to open surgery and comparable to a VATS approach. Long-term follow-up is required to further delineate oncological outcomes., Competing Interests: Conflicts of Interest: US Kreaden is principal biostatistician and AE Hebert is a scientific consultant for Intuitive Surgical. They were responsible for the initial searches. The other authors have no conflicts of interest to declare.

Background: Skill assessment during robotically assisted surgery remains challenging. While the popularity of the Global Evaluative Assessment of Robotics Skills (GEARS) has grown, its lack of discrimination between independent console skills limits its usefulness. The purpose of this study was to evaluate construct validity and interrater reliability of a novel assessment designed to overcome this limitation., Methods: We created the Assessment of Robotic Console Skills (ARCS), a global rating scale with six console skill domains. Fifteen volunteers who were console surgeons for 0 ("novice"), 1-100 ("intermediate"), or >100 ("experienced") robotically assisted procedures performed three standardized tasks. Three blinded raters scored the task videos using ARCS, with a 5-point Likert scale for each skill domain. Scores were analyzed for evidence of construct validity and interrater reliability., Results: Group demographics were indistinguishable except for the number of robotically assisted procedures performed (p = 0.001). The mean scores of experienced subjects exceeded those of novices in dexterity (3.8 > 1.4, p < 0.001), field of view (4.1 > 1.8, p < 0.001), instrument visualization (3.9 > 2.2, p < 0.001), manipulator workspace (3.6 > 1.9, p = 0.001), and force sensitivity (4.3 > 2.6, p < 0.001). The mean scores of intermediate subjects exceeded those of novices in dexterity (2.8 > 1.4, p = 0.002), field of view (2.8 > 1.8, p = 0.021), instrument visualization (3.2 > 2.2, p = 0.045), manipulator workspace (3.1 > 1.9, p = 0.004), and force sensitivity (3.7 > 2.6, p = 0.033). The mean scores of experienced subjects exceeded those of intermediates in dexterity (3.8 > 2.8, p = 0.003), field of view (4.1 > 2.8, p < 0.001), and instrument visualization (3.9 > 3.2, p = 0.044). Rater agreement in each domain demonstrated statistically significant concordance (p < 0.05)., Conclusions: We present strong evidence for construct validity and interrater reliability of ARCS. Our study shows that learning curves for some console skills plateau faster than others. Therefore, ARCS may be more useful than GEARS to evaluate distinct console skills. Future studies will examine why some domains did not adequately differentiate between subjects and applications for intraoperative use.

Introduction: The primary aims of this study were to assess the learning curve effect of robot-assisted radical prostatectomy (RARP) in a large administrative database consisting of multiple U.S. hospitals and surgeons, and to compare the results of RARP with open radical prostatectomy (ORP) from the same settings., Materials and Methods: The patient population of study was from the Premier Perspective Database (Premier, Inc., Charlotte, NC) and consisted of 71,312 radical prostatectomies performed at more than 300 U.S. hospitals by up to 3739 surgeons by open or robotic techniques from 2004 to 2010. The key endpoints were surgery time, inpatient length of stay, and overall complications. We compared open versus robotic, results by year of procedures, results by case volume of specific surgeons, and results of open surgery in hospitals with and without a robotic system., Results: The mean surgery time was longer for RARP (4.4 hours, standard deviation [SD] 1.7) compared with ORP (3.4 hours, SD 1.5) in the same hospitals (p<0.0001). Inpatient stay was shorter for RARP (2.2 days, SD 1.9) compared with ORP (3.2 days, SD 2.7) in the same hospitals (p<0.0001). The overall complications were less for RARP (10.6%) compared with ORP (15.8%) in the same hospitals, as were transfusion rates. ORP results in hospitals without a robot were not better than ORP with a robot, and pretreatment co-morbidity profiles were similar in all cohorts. Trending of results by year of procedure showed no differences in the three cohorts, but trending of RARP results by surgeon experience showed improvements in surgery time, hospital stay, conversion rates, and complication rates., Conclusions: During the initial 7 years of RARP development, outcomes showed decreased hospital stay, complications, and transfusion rates. Learning curve trends for RARP were evident for these endpoints when grouped by surgeon experience, but not by year of surgery.

Background: Strategies to spare operating room (OR) times are crucial to limiting the costs involved in robotic surgery. Among other factors, the pre-operative set-up and docking phases have been incriminated at first to be time consuming. The docking process on the standard multiport da Vinci Surgical System has not been shown to significantly prolong the overall OR time. This study aims to analyse whether the length of the docking process on the new da Vinci Si Surgical System with Single-Site™ technology remains acceptable., Methods: We prospectively analysed all of the robotic single-incision cholecystectomies performed at our institution for docking and operating times during 2011-2012. The docking task load was assessed each time in a self-administered fashion by the docking surgeon using the NASA TLX visual scale., Results: Sixty-four robotic single-incision cholecystectomies were included and analysed. The mean operative time was 78 min. Two surgeons with previous robotic surgery experience and a group of three less experienced robotic surgeons were responsible for docking the system. They performed 45, 10 and nine dockings, respectively. The overall mean docking time was 6.4 min with no significant difference between the groups. The docking process represented approximately 8% of the operating time. The surgeon with the most procedures showed significant progress in his docking times. The different task load parameters did not show a statistical difference between the three groups, with the exception of the frustration parameter, which was higher in the group of less experienced surgeons. There were significant correlations between docking times and the assessment of the various task load parameters., Conclusion: The docking process for a robotic single-incision cholecystectomy is learned rapidly and does not significantly increase the overall OR time., (Copyright © 2013 John Wiley & Sons, Ltd.)

Objective: To relate vaginal fetal fibronectin levels in women with symptoms of preterm labor to subsequent spontaneous preterm birth., Methods: Quantitative fetal fibronectin values were calculated from women who participated in two prospective multicenter trials relating fetal fibronectin to subsequent spontaneous preterm birth. The study populations consisted of women who presented with symptoms of preterm labor between 24(0)/(7) and 34(6)/(7) weeks, a singleton pregnancy, intact membranes, no prior tocolysis, and cervical dilation less than 3 cm., Results: The characteristics of the two study populations were similar. In both populations, the rates of delivery within 7, 14, and 21 days after sampling were clustered into three distinct fetal fibronectin groups (less than 40, 40-100, and 100 ng/mL or more). As fetal fibronectin values increased, the risk of subsequent spontaneous preterm birth also increased. Delivery within 7 days of sampling was 0.4%, 3.3%, and 18.2% (trial A) and 1.4%, 8.0%, 30.0% (trial B) as the fetal fibronectin levels increased from less than 40 ng/mL, to 40-100 ng/mL, and to at least 100 ng/mL, respectively., Conclusion: In women with symptoms of preterm labor, an increase in fetal fibronectin from under 40 ng/mL, to 40-100 ng/mL, to at least 100 ng/mL was associated with a progressive increase in the risk of subsequent spontaneous preterm birth. The use of a single fetal fibronectin cutoff of 50 ng/mL for defining a positive test in women with symptoms of preterm labor should be reevaluated.

Objective: To investigate the relationship between fetal fibronectin and bacterial vaginosis, which are associated with an increased risk for preterm delivery., Methods: Researchers for the Pregnancy, Infection and Nutrition Study, a cohort study of pregnant women at three central North Carolina sites, collected genital tract specimens from all enrolled women between 24 and 29 weeks' gestation. Among women with last menstrual periods between March 10, 1995, and August 15, 1996, 868 pregnancies were eligible for this analysis. Fetal fibronectin was assessed by a dipstick immunoassay kit. Bacterial vaginosis was evaluated by Nugent-scored, Gram-stained vaginal smears (scores of 7-10 considered positive)., Results: Overall, 6.3% of women had positive fetal fibronectin test results, and 18.8% had bacterial vaginosis. The unadjusted relative risk (RR) of fetal fibronectin-positivity comparing women with bacterial vaginosis to those without bacterial vaginosis was 1.6 (95% confidence interval [CI] 1.1, 2.5). Using multiple logistic regression to adjust for race, maternal age, parity, and location of care, women who had bacterial vaginosis and smoked at the time of recruitment were at substantially increased risk of fetal fibronectin-positivity (RR 7.8, 95% CI 2.2, 27.8) compared with smokers without bacterial vaginosis. Among nonsmokers, bacterial vaginosis was not associated with fetal fibronectin-positivity (RR 1.0, 95% CI 0.4, 2.4). These results were essentially unchanged after adding the requirement of vaginal pH exceeding 4.5 to the bacterial vaginosis definition., Conclusion: Fetal fibronectin was associated positively with bacterial vaginosis, but only among women who smoked. These results might provide clues as to the biologic relationship between smoking, infection, and preterm delivery.

Objective: The purpose of this study was to evaluate the association of vaginal fetal fibronectin expression to risk of preterm delivery and delivery of very-low-birth-weight infants., Study Design: Vaginal secretions were obtained from women between 22 and 35 weeks' pregnant with minimal cervical dilation (< or = 2 cm) and threatened preterm delivery. The secretions were analyzed for the presence of fetal fibronectin. Other clinical information including cervical dimensions, uterine activity, serum C-reactive protein concentration, vaginal pH, evidence of vaginal or systemic infection, and vaginal bleeding were also obtained., Results: Of the 112 patients recruited, 40 (35.7%) were delivered prematurely (<37 weeks). For prediction of preterm delivery, the fetal fibronectin test result had a sensitivity, specificity, and positive and negative predictive values of 67.5, 90.3, 79.4, and 83.3%, respectively (odds ratio 19.3, p < 0.0001). Women with a positive fetal fibronectin test had a nearly 13-fold increased probability of being delivered of an infant weighing <1500 gm than did women with a negative fetal fibronectin test (32.4% vs 2.5%, p<0.0001). Categoric analysis and multiple logistic regression demonstrated that fetal fibronectin was an independent risk factor for prediction of preterm delivery and birth weight <1500 gm., Conclusion: Vaginal fetal fibronectin expression is an independent risk factor for preterm delivery and birth of very-low-birth-weight infants in symptomatic women with intact amniotic membranes and minimal cervical dilatation.

Objective: Our purpose was to assess the utility of cervicovaginal expression of fetal fibronectin in the diagnosis of preterm labor., Study Design: Women seen between 24 and 34 weeks' gestation with symptoms of preterm labor, intact membranes, and cervical dilatation < 3 cm were enrolled at five university medical centers. Cervicovaginal swabs were obtained and assayed for the presence of fetal fibronectin by means of a monoclonal antibody assay. Results were compared with cervical dilatation and uterine contraction frequency as indicators of interval to delivery and delivery before 37 weeks., Results: A total of 192 eligible women at a mean gestational age of 30.8 +/- 2.9 weeks were enrolled from a population of 418 subjects screened. The rate of preterm birth was 32.3% (62/192). The mean interval from presentation to delivery was 25.3 +/- 24.1 days in the 45 subjects with a positive fibronectin assay and 52.4 +/- 24.8 days in the 147 subjects with a negative assay (p = 0.0001). The sensitivity, specificity, and positive and negative predictive values of fetal fibronectin expression for delivery < 37 weeks were 44% (27/62), 86% (112/130), 60% (27/45), and 76% (112/147). The fetal fibronectin assay was especially useful in predicting risk of delivery within 7 days (sensitivity 93% [13/14], specificity 82% [146/178], positive predictive value 29% [13/45], and negative predictive value 99% [146/147]) and was notably superior to both cervical dilatation > 1 cm and contraction frequency greater than or equal to eight per hour (sensitivities 29% and 42%, specificities 82% and 67%, positive predictive values 11% and 9%, and negative predictive values 94% and 94%, respectively., Conclusion: Cervicovaginal fetal fibronectin predicts delivery within 7 days more accurately than do cervical dilatation and contraction frequency in a population of women evaluated for early preterm labor.