Transvaginal Ultrasound Screening Research Articles

Introduction of universal transvaginal cervical length measurement does not decrease spontaneous preterm delivery rate compared to universal transabdominal screening with reflex cut‐off: A pre‐post study

AbstractObjectivesThe objective of our study is to examine cervical length measurements, identification of short cervix, vaginal progesterone use, and rate of spontaneous preterm delivery before and after departmental transition to a universal transvaginal ultrasound screening protocol from a universal transabdominal screening protocol.MethodsThis is a retrospective observational pre–post study examining the year prior to and year following a transition to a universal transvaginal ultrasound screening protocol to assess cervical length at the time of the anatomy survey. Prior to this transition, universal transabdominal cervical length screening was performed, with reflex transvaginal ultrasound measurement if transabdominal measurement was <35 mm or was unable to be obtained.ResultsA total of 1760 charts were reviewed; 962 charts were from the pre‐transition/transabdominal year and 798 charts were from the post‐transition/transvaginal year. In the post‐transition/transvaginal year, cervical length less than 20 mm was identified in 1.5% of cases, compared to 0.7% of cases in the pre‐transition/transabdominal year (p = 0.114). There was no difference in the rate of spontaneous preterm delivery between the two groups (5.1% in the pre‐transition/transabdominal year vs. 6.9% in the post‐transition/transvaginal year; p = 0.111).ConclusionsIn this pre‐post study, introduction of a universal transvaginal cervical length screening did not decrease spontaneous preterm delivery rates or detection of short cervix <20 mm, compared to a protocol of universal transabdominal cervical length screening with reflex to transvaginal for measurement <35 mm.

P-311 Impact of adenomyosis on reproductive outcomes applying the revised Morphological Uterus Sonographic Assessment criteria in fresh donor oocyte recipients pretreated with GnRH agonist

Abstract Study question Could the diagnosis of adenomyosis (AD) impact reproductive outcomes when applying the revised Morphological Uterus Sonographic Assessment (MUSA) criteria in fresh donor oocyte cycles? Summary answer Adenomyosis diagnosis following the revised MUSA criteria in recipients did not have adversely affect reproductive outcomes in fresh donor oocyte recipients pretreated with GnRH agonist What is known already Prior metanalysis on IVF outcomes in patients with adenomyosis suggested lower clinical pregnancy and live birth rates, and increased miscarriage rates. Some studies suggest improved pregnancy rates with ultra-long GnRH agonist pretreatment. Most studies focused on autologous embryo transfer without euploidy confirmation, and diagnostic criteria lacked consensus, in 2021 MUSA redefined criteria distinguishing direct and indirect features with different implications. Study design, size, duration A retrospective cohort study included all fresh oocyte donation cycles from January 2014 to September 2023, evaluating adenomyosis impact on implantation rate, clinical pregnancy rate, miscarriage rate, ectopic pregnancy rate. The study analyzed 252 cycles without a formal sample size calculation due to its retrospective nature. Participants/materials, setting, methods The study included 252 first fresh oocyte reception cycle with a fresh embryo transfer. Severe male factor cases were excluded. A transvaginal ultrasound (TUS) screening for adenomyosis criteria was performed, diagnosis required at least two criteria, with one being direct. Endometrial preparation involved one dose of 3,75mg triptorelin acetate intramuscularly injected in mid luteal phase, to facilitate the synchronization with donor and estradiol patches. Main results and the role of chance Adenomyosis was diagnosed in 10,7% (AD), endometriosis (END) was present in 21,8 % and 26,6% of patients presented both diagnoses. Endometriosis patients received more pre-treatment (oral contraceptive or 2-3 long-agonist doses) than those without (40,7% AD, 43,6% END vs 17,3% non-AD/END). Comparing patients with and without adenomyosis, no statistical differences were found in embryo transfer results between groups: clinical pregnancy rate (63% vs 56,9%), miscarriage rate (23,5% vs 14,1%), ectopic pregnancy rate (11,8% vs 4,7%) and live birth rate (40,7% vs 45,8%). No differences in gestational outcomes were observed in terms of the number of adenomyosis criteria present, the number of direct criteria, the type of criteria, or when differentiating between focal and diffuse adenomyosis. Similarly, there were no differences when comparing patients with both diagnoses to those with isolated adenomyosis. The most prevalent adenomyosis features reported were hyperechogenic islands (direct criteria), followed by an irregular junctional zone and asymmetrical wall thickening (indirect criteria). Finally, no differences were found in perinatal outcomes or complications during the pregnancy follow-up between groups. Limitations, reasons for caution Although this is the largest serie evaluating adenomyosisto the low adenomyosis prevalence in our population, these results should be confirmed in larger series. In our center all adenomyosis/endometriosis symptomatic patients are under medical treatment before assisted reproduction techniques, that may modify adenomyosis criteria over time and probably pregnancy outcomes. Wider implications of the findings This is the first study to characterize adenomyosis using the revised MUSA definitions in an oocyte donation programme. Applying these criteria and preparing endometrium with GnRH analog pretreatment and treating medically symptomatic patients before ART, adenomyosis did not adversely affect reproductive outcomes. Trial registration number Not applicable

Early first-trimester transvaginal ultrasound screening for cesarean scar pregnancy in patients with previous cesarean delivery: analysis of the evidence

Obstetric hemorrhage is a leading cause of maternal morbidity and mortality. An important etiology of obstetric hemorrhage is placenta accreta spectrum. In the last two decades, there has been increased clinical experience of the devastating effect of undiagnosed, as well as late diagnosed, cases of Cesarean scar pregnancy. There is a growing body of evidence suggesting that Cesarean scar pregnancy is an early precursor of second- and third-trimester placenta accreta spectrum. As such, Cesarean scar pregnancy should be diagnosed in the early first trimester. This early diagnosis could be achieved by introducing regimented sonographic screening in pregnancies of patients with previous Cesarean delivery. This Opinion article evaluates the scientific and clinical basis of whether Cesarean scar pregnancy, with special focus on its early first-trimester discovery, complies with the accepted requirements of a screening test. Each of the 10 classical screening criteria of Wilson and Jungner were systematically applied to evaluate if the criteria were met by Cesarean scar pregnancy, to analyze if it is possible and realistic to carry out screening in a population-wide fashion.

Concept of opportunistic bilateral salpingectomy in a sample of Mexican gynecologists. What should residents be trained on?

BackgroundOvarian cancer is the fifth deadliest cancer among women. There is no effective screening method. It has been suggested that ovarian cancer originates from precursor lesions in the fimbriae of the fallopian tubes. ObjectiveThe aim of this study was to determine the level of knowledge of opportunistic bilateral salpingectomy by gynecologists. MethodsA cross-sectional study was carried out and a survey was sent electronically to gynecologists and gynecology residents. Demographic characteristics as well as questions of interest related to clinical practice and indication for surgery were included. Results52 subjects were included, 21 women and 31 men, with a mean age of 40.7 years. Thirty-five board certified gynecologists, as well as 17 gynecology residents, were included as part of the total survey group. Thirty-six individuals (69.2%) reported performing elective salpingectomy. The motivation they had to perform salpingectomy as a method of sterilization was: “reduction in the risk of ovarian cancer in the future” (55.6%). The indication for elective salpingectomy while performing other procedures was: “to prevent ovarian cancer” (61.1%). Certified gynecologists (42.9%) as well as residents (41.1%) considered “transvaginal ultrasound screening” as the best primary prevention method for ovarian cancer in low-risk women. ConclusionsOpportunistic bilateral salpingectomy is safe and cost-effective. However, when gynecologists are interviewed to find out their level of knowledge, there is poor acceptance of opportunistic bilateral salpingectomy in Mexico. A training strategy should be designed in the gynecology residency in order to motivate ovarian cancer prevention.

OP05.06: Transabdominal ultrasound combined with transvaginal ultrasound screening for fetal cardiac abnormalities in early pregnancy

OP05.06: Transabdominal ultrasound combined with transvaginal ultrasound screening for fetal cardiac abnormalities in early pregnancy

Early prenatal diagnosis of double inlet left ventricle

Objective The aim of this study to describe the presentation of double inlet left ventricle (DILV) very early in prenatal life, to assess its prevalence and to portray the associated anomalies. Methods This was a retrospective study which included all the women who attended our clinic for early fetal screening sonography, between 2006 and 2020. Most of the screening was done at 14–16 weeks of gestation (except one high risk pregnancy, which was performed at nine gestational weeks), and included an anatomic fetal scan and Doppler imaging. The diagnosis of DILV was done based on sonographic features of abnormal four-chamber view. Complete fetal echocardiography was carried out to rule out additional heart malformations. Results Out of 26,805 early prenatal transvaginal ultrasound screening examinations, 14 cases of DILV were diagnosed. The gestational age range of our DILV diagnosis was 9–16 gestational weeks. All pregnancies were terminated as per parental request. In five fetuses, a chromosomal analysis was performed, one had trisomy 21, and the rest fetuses had a normal karyotype. In two fetuses, an autopsy was performed and the diagnosis of DILV was confirmed in both. Conclusions Very early prenatal detection of DILV is possible and may have an implication in parent decision regarding their pregnancy future.

Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

SummaryBackgroundOvarian cancer continues to have a poor prognosis with the majority of women diagnosed with advanced disease. Therefore, we undertook the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) to determine if population screening can reduce deaths due to the disease. We report on ovarian cancer mortality after long-term follow-up in UKCTOCS.MethodsIn this randomised controlled trial, postmenopausal women aged 50–74 years were recruited from 13 centres in National Health Service trusts in England, Wales, and Northern Ireland. Exclusion criteria were bilateral oophorectomy, previous ovarian or active non-ovarian malignancy, or increased familial ovarian cancer risk. The trial management system confirmed eligibility and randomly allocated participants in blocks of 32 using computer generated random numbers to annual multimodal screening (MMS), annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. Follow-up was through national registries. The primary outcome was death due to ovarian or tubal cancer (WHO 2014 criteria) by June 30, 2020. Analyses were by intention to screen, comparing MMS and USS separately with no screening using the versatile test. Investigators and participants were aware of screening type, whereas the outcomes review committee were masked to randomisation group. This study is registered with ISRCTN, 22488978, and ClinicalTrials.gov, NCT00058032.FindingsBetween April 17, 2001, and Sept 29, 2005, of 1 243 282 women invited, 202 638 were recruited and randomly assigned, and 202 562 were included in the analysis: 50 625 (25·0%) in the MMS group, 50 623 (25·0%) in the USS group, and 101 314 (50·0%) in the no screening group. At a median follow-up of 16·3 years (IQR 15·1–17·3), 2055 women were diagnosed with tubal or ovarian cancer: 522 (1·0%) of 50 625 in the MMS group, 517 (1·0%) of 50 623 in the USS group, and 1016 (1·0%) of 101 314 in the no screening group. Compared with no screening, there was a 47·2% (95% CI 19·7 to 81·1) increase in stage I and 24·5% (−41·8 to –2·0) decrease in stage IV disease incidence in the MMS group. Overall the incidence of stage I or II disease was 39·2% (95% CI 16·1 to 66·9) higher in the MMS group than in the no screening group, whereas the incidence of stage III or IV disease was 10·2% (−21·3 to 2·4) lower. 1206 women died of the disease: 296 (0·6%) of 50 625 in the MMS group, 291 (0·6%) of 50 623 in the USS group, and 619 (0·6%) of 101 314 in the no screening group. No significant reduction in ovarian and tubal cancer deaths was observed in the MMS (p=0·58) or USS (p=0·36) groups compared with the no screening group.InterpretationThe reduction in stage III or IV disease incidence in the MMS group was not sufficient to translate into lives saved, illustrating the importance of specifying cancer mortality as the primary outcome in screening trials. Given that screening did not significantly reduce ovarian and tubal cancer deaths, general population screening cannot be recommended.FundingNational Institute for Health Research, Cancer Research UK, and The Eve Appeal.

Sonographic detection of fetal abnormalities before 11 weeks of gestation.

Sonographic detection of fetal abnormalities before 11 weeks of gestation.

Cervical assessment by ultrasound for preventing preterm delivery.

Measurement of cervical length by ultrasound is predictive of preterm birth (PTB). There are three methods of ultrasound cervical assessment: transvaginal (TVU), transabdominal (TAU), and transperineal (TPU, also called translabial). Cervical length measured by TVU is a relatively new screening test, and has been associated with better prediction of PTB than previously available tests. It is unclear if cervical length measured by ultrasound is effective for preventing PTB. This is an update of a review last published in 2013. To assess the effectiveness of antenatal management based on transvaginal, transabdominal, and transperineal (also called translabial) ultrasound screening of cervical length for preventing preterm birth. For this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) to 30 August 2018; reviewed the reference lists of all articles, and contacted experts in the field for additional and ongoing trials. We included published and unpublished randomised controlled trials (RCT) including pregnant women between the gestational ages of 14 to 32 weeks, for whom the cervical length was screened for risk of PTB with TVU, TAU, or TPU. This review focused on studies based on knowledge versus no knowledge of cervical length results, or ultrasound versus no ultrasound for cervical length. We excluded studies based on interventions (e.g. progesterone, cerclage) for short cervical length. We followed standard Cochrane methods. We included seven RCTs (N = 923): one examined asymptomatic women with twin pregnancies; four included women with singleton pregnancies and symptoms of preterm labour (PTL); one included women with singleton pregnancies and symptoms of preterm premature rupture of membranes (PPROM); and one included asymptomatic singletons. All trials used TVU for screening.We assessed the risk of bias of the included studies as mixed, and the quality of the evidence for primary outcomes as very low for all populations.For asymptomatic women with twin pregnancies, it is uncertain whether knowledge of TVU-measured cervical length compared to no knowledge reduces PTB at less than 34 weeks (risk ratio (RR) 0.62, 95% confidence intervals (CI) 0.30 to 1.25; 1 study, 125 participants) because the quality of the evidence is very low. The results were also inconclusive for preterm birth at 36, 32, or 30 weeks; gestational age at birth, and other maternal and perinatal outcomes.Four trials examined knowledge of TVU-measured cervical length of singletons with symptoms of PTL versus no knowledge. We are uncertain of the effects because of inconclusive results and very low-quality evidence for: preterm births at less than 37 weeks (average RR 0.59, 95% CI 0.26 to 1.32; 2 studies, 242 participants; I² = 66%; Tau² = 0.23). Birth occurred about four days later in the knowledge groups (mean difference (MD) 0.64 weeks, 95% CI 0.03 to 1.25; 3 trials, 290 women). The results were inconclusive for the other outcomes for which there were available data: PTB at less than 34 or 28 weeks; birthweight less than 2500 g; perinatal death; maternal hospitalisation; tocolysis; and steroids for fetal lung maturity.The trial of singletons with PPROM (N = 92) evaluated safety of using TVU to measure cervical length in this population as its primary outcome, not its effect on management. The results were inconclusive for incidence of maternal and neonatal infections between the TVU and no ultrasound groups.In the trial of asymptomatic singletons (N = 296), in which women either received TVU or not, the results were inconclusive for preterm birth at less than 37 weeks (RR 1.27, 95% CI 0.61 to 2.61; I² = 0%), gestational age at birth, and other perinatal and maternal outcomes.We downgraded evidence for limitations in study design, inconsistency between the trials, and imprecision, due to small sample size and wide confidence intervals crossing the line of no effect.No trial compared the effect of knowledge of the CL with no knowledge of CL in other populations, such as asymptomatic women with singleton pregnancies, or symptomatic women with twin pregnancies. There are limited data on the effects of knowing the cervical length, measured by ultrasound, for preventing preterm births, which preclude us from drawing any conclusions for women with asymptomatic twin or singleton pregnancies, singleton pregnancies with PPROM, or other populations and clinical scenarios.Limited evidence suggests that knowledge of transvaginal ultrasound-measured cervical length, used to inform the management of women with singleton pregnancies and symptoms of preterm labour, appears to prolong pregnancy by about four days over women in the no knowledge groups.Future studies could look at specific populations separately (e.g. singleton versus twins; symptoms versus no symptoms of PTL), report on all pertinent maternal and perinatal outcomes, and include cost-effectiveness analyses. Most importantly, future studies should include a clear protocol for management of women based on TVU-measured cervical length.

Serum HE4 and diagnosis of ovarian cancer in postmenopausal women with adnexal masses

BackgroundTransvaginal ultrasound and serum CA125 are routinely used for differential diagnosis of pelvic adnexal mass. Use of human epididymis 4 was approved in the United States in 2011. However, there is scarcity of studies evaluating the additional value of human epididymis 4.ObjectiveThe objective of the study was to evaluate the performance characteristics of transvaginal ultrasound, CA125, and human epididymis 4 for differential diagnosis of ovarian cancer in postmenopausal women with adnexal masses.Study DesignThis was a cohort study nested within the screen arms of the multicenter randomized controlled trial, United Kingdom Collaborative Trial of Ovarian Cancer Screening, based in England, Wales, and Northern Ireland. In United Kingdom Collaborative Trial of Ovarian Cancer Screening, 48,230 women randomized to transvaginal ultrasound screening and 50,078 to multimodal screening (serum CA125 interpreted by Risk of Ovarian Cancer Algorithm with second line transvaginal ultrasound) underwent the first (prevalence) screen. Women with adnexal lesions and/or persistently elevated risk were clinically assessed and underwent surgery or follow-up for a median of 10.9 years. Banked samples taken within 6 months of transvaginal ultrasound from all clinically assessed women were assayed for human epididymis 4 and CA125. Area under the curve and sensitivity for diagnosing ovarian cancer of multiple penalized logistic regression models incorporating logCA125, log human epididymis 4, age, and simple ultrasound features of the adnexal mass were compared.ResultsOf 1590 (158 multimodal, 1432 ultrasound) women with adnexal masses, 78 were diagnosed with ovarian cancer (48 invasive epithelial ovarian, 14 type I, 34 type II; 24 borderline epithelial; 6 nonepithelial) within 1 year of scan. The area under the curve (0.893 vs 0.896; P = .453) and sensitivity (74.4% vs 75.6% ;P = .564) at fixed specificity of 90% of the model incorporating age, ultrasound, and CA125 were similar to that also including human epididymis 4. Both models had high sensitivity for invasive epithelial ovarian (89.6%) and type II (>91%) cancers.ConclusionOur population cohort study suggests that human epididymis 4 adds little value to concurrent use of CA125 and transvaginal ultrasound in the differential diagnosis of adnexal masses in postmenopausal women.

Universal cervical length screening with a cervicometer to prevent preterm birth

Background: Preterm birth is a leading cause of neonatal morbidity and mortality worldwide; evidence-based strategies to decrease preterm birth are desperately needed.Objective: The purpose of this study was to estimate which of three strategies for screening for shortened cervix in asymptomatic low-risk women is the most cost-effective in terms of prevention of preterm birth and associated morbidity.Study design: A decision analysis model was developed from available published evidence comparing three strategies in screening asymptomatic low-risk women for shortened cervix: (1) cervicometer with subsequent referral for transvaginal ultrasound, (2) transvaginal ultrasound screening, and (3) no screening. The cost and effectiveness of each strategy was assessed in terms of quality-adjusted life-years (QALYs), and cost in US dollars.Results: Screening with a cervicometer with referral was the most cost-effective strategy and represented a savings of $999.65 ($11,617.28 versus $12,616.93) over screening with ultrasound, and a savings of $15,601.62 ($11,617.28 versus $27,218.90) over no screening. Costs for outcomes ranged from $3528 for a healthy neonate ≥34 weeks to $717,467.5 for a neonate <34 weeks with severe morbidity. The cervicometer strategy avoided 11.68 neonatal deaths per 1000 deliveries (3.59 deaths versus 15.27 deaths) compared with no screening, and avoided 0.73 neonatal deaths per 1000 deliveries (3.59 deaths versus 4.32 deaths) compared with ultrasound strategy. The cervicometer strategy prevented 82.44 preterm births per 1000 deliveries (22.56 versus 105.00) compared with no screening, and 5.10 preterm births per 1000 deliveries (22.56 versus 27.66) compared with ultrasound strategy. Per QALY, cervicometer screening cost $386.57, transvaginal ultrasound cost $420.31, and no screening cost $922.73. Sensitivity analyses confirmed the robustness of these findings, including evaluation across the range of quoted transvaginal ultrasound costs ($43–$300).Conclusion: A simulation of universal screening of asymptomatic low-risk women with a cervicometer with subsequent referral for ultrasound for those with a cervix <25 mm is cost-effective and yields the greatest reduction in preterm births at <34 weeks. A risk simulation trial noted that a cervicometer strategy may be more expensive than a universal transvaginal ultrasound strategy, but both are less expensive than a no screening strategy.

Vasa previa screening strategies: decision and cost-effectiveness analysis.

To perform a decision and cost-effectiveness analysis comparing four screening strategies for the antenatal diagnosis of vasa previa in singleton pregnancies. A decision-analytic model was constructed comparing vasa previa screening strategies. Published probabilities and costs were applied to four transvaginal screening scenarios that were carried out at the time of mid-trimester ultrasound: no screening, ultrasound-indicated screening, screening only pregnancies conceived by in-vitro fertilization (IVF) and universal screening. Ultrasound-indicated screening was defined as performing transvaginal ultrasound at the time of the routine anatomy ultrasound scan in response to one of the following sonographic findings associated with an increased risk of vasa previa: low-lying placenta, marginal or velamentous cord insertion or bilobed or succenturiate lobed placenta. The primary outcome was cost per quality-adjusted life year (QALY) in US$. The analysis was performed from a healthcare system perspective with a willingness-to-pay threshold of $100 000 per QALY selected. One-way and multivariate sensitivity analysis (Monte-Carlo simulation) was performed. This decision-analytic model demonstrated that screening pregnancies conceived by IVF was the most cost-effective strategy, with an incremental cost effectiveness ratio (ICER) of $29186.50/QALY. Ultrasound-indicated screening was the second most cost-effective, with an ICER of $56096.77/QALY. These data were robust to all one-way and multivariate sensitivity analyses performed. Within the baseline assumptions, transvaginal ultrasound screening for vasa previa appears to be most cost-effective when performed among IVF pregnancies. However, both IVF and ultrasound-indicated screening strategies fall within contemporary willingness-to-pay thresholds, suggesting that both strategies may be appropriate to apply in clinical practice. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Ovarian Cancer Prevention and Screening.

There has been much progress in ovarian cancer screening and prevention in recent years. Improved tools that combine genetic and epidemiologic factors to predict an individual's ovarian cancer risk are set to become available for tailoring preventive and screening approaches. The increasing evidence on tubal origins of a proportion of ovarian cancer has paved the way to use of opportunistic bilateral salpingectomy at tubal ligation and hysterectomy in the general population. Clinical trials are in progress to estimate the long-term effects on endocrine function. In women at high risk, risk reducing salpingo-oophorectomy remains the standard of care with the current focus on management of resulting noncancer outcomes, especially sexual dysfunction in younger women. This has led to evaluation of early bilateral salpingectomy and delayed oophorectomy in this population. Meanwhile, modeling suggests that BRCA mutation carriers should consider using the oral contraceptive pill for chemoprevention. In the general population, the largest ovarian cancer screening trial to date, the UK Collaborative Trial of Ovarian Cancer Screening reported a stage shift with annual multimodal screening using the longitudinal CA 125 Risk of Ovarian Cancer Algorithm but not with annual transvaginal ultrasound screening. There was no definitive mortality reduction with either screening strategy compared with no screening. Further follow-up until December 2018 in now underway. Stage shift and higher rates of optimal cytoreduction were also reported during 3- to 4-monthly multimodal screening in the United Kingdom and U.S. high-risk screening trials. Although all agree that there is not yet evidence to support general population screening, recommendations for high-risk screening vary between countries. A key finding from the screening trials has been the better performance of longitudinal algorithms compared with a single cutoff for CA 125. A major focus of ovarian cancer biomarker discovery work has been tumor DNA markers in both plasma and novel specimens such as cervical cytology samples.

Decrease in the incidence of threatened preterm labor after implementation of transvaginal ultrasound cervical length universal screening

Background It is unknown if universal second-trimester transvaginal ultrasound (TVU) cervical length (CL) screening in asymptomatic women with singleton gestations and no prior spontaneous preterm birth (SPTB) affects the incidence of symptoms of preterm labor (PTL) later in pregnancy. Objective To evaluate the incidence of threatened PTL before and after the implementation of universal second trimester TVU CL screening. Study design This was a retrospective cohort study of all consecutive singleton gestations without prior SPTB presenting to obstetric triage for threatened PTL between 23 0/7 and 33 6/7 week in 2011 (1 January–31 December), and in 2014 (1 January–31 December) at Thomas Jefferson University Hospital (TJU) (Philadelphia, PA). These 2 years were chosen as a new protocol for universal TVU CL screening was started on 1 January 2012. This protocol involved one measurement of TVU CL in all singleton gestations without a prior SPTB at 18 0/7 − 23 6/7 week, the time of the “anatomy” scan. Women with prior SPTB were excluded from this study. The primary outcome included the incidence of threatened PTL, defined as the number of women with singleton gestations without prior SPTB who presented with threatened PTL to our labor and delivery (L&D) triage unit annually, divided by the total number of annual deliveries of women with singleton gestation without prior SPTB. Secondary outcomes were the incidence of PTL, defined as the number of women with singleton gestations without prior SPTB admitted for PTL annually divided by the total number of annual deliveries of women with singleton gestation and without prior SPTB; and length of stay in the hospital. We aimed to compare primary and secondary outcome in the “2011” versus the “2014” group. Results In 2011, there were a total of 1745 deliveries at TJU, of which 1550 (88.8%) were singletons without prior SPTB. In 2014, there were a total of 1924 deliveries at TJU, 1751 (91.0%) were singletons without prior SPTB who were offered universal TVU CL screening. One hundred and seventy-two women with singletons without prior SPTB presented in L&D triage unit in 2011; and 118 women with singletons without prior SPTB presented in L&D triage unit in 2014. There were significant decreases in the incidence of threatened PTL from 11.1% (172/1550) in 2011 to 6.7% (118/1751) in 2014 (p < .001), as well as in the rate of admission for PTL from 2.3% (35/1550) to 1.4% (24/1751), respectively (p = .04). Length of stay was not significantly different between the two groups. Conclusion The introduction of a universal TVU CL screening program in women with singleton gestations without a history of SPTB is associated with a reduction in the frequency of threatened PTL and admission for PTL. Key Message The introduction of a second trimester universal transvaginal ultrasound (TVU) cervical length (CL) screening program in women without a history of spontaneous preterm birth (SPTB) is associated with a reduction in the incidence of threatened preterm labor (PTL) and admission for PTL.

Universal Cervical Length Screening and Antenatal Corticosteroid Timing.

To evaluate the relationship between universal transvaginal screening for short cervical length in the second trimester and the timing of antenatal corticosteroids. We performed a retrospective cohort study of patients with nonanomalous singleton gestations and spontaneous preterm birth between 24 and 34 weeks of gestation after the initiation of a universal transvaginal cervical length screening program between October 2012 and August 2015. Our primary outcome was antenatal corticosteroid administration to a delivery interval of fewer than 7 days. Secondary outcomes were delivery 24 hours to 7 days after the initial steroid injection, steroid administration to delivery interval, neonatal survival, neonatal intensive care unit length of stay, and respiratory distress syndrome. Multivariable logistic regression was used to estimate the association between antenatal corticosteroid timing and the diagnosis of a short cervix adjusted for potential confounders. Among 266 eligible patients, 69 with a short cervical length and 197 without a short cervical length were identified. There were no statistically significant differences in baseline characteristics between the groups. During the study period, 64 of 69 (92.8%) of patients with a short cervix and 176 of 197 (89.3%) without a short cervix received at least one steroid injection before delivery (P=.411). Steroids were given within 7 days of delivery in 33 of 69 (47.8) patients with a short cervix compared with 126 of 197 (64%) patients in the no short cervix group (P=.015; adjusted odds ratio 0.51, 95% confidence interval 0.29-0.9). Median interval between steroid administration and delivery was 8 days in patients diagnosed with a short cervix compared with 3 days for those without a short cervical length (P<.001). Patients identified as having a short cervical length by universal transvaginal ultrasound screening were at greater risk of delivering more than 7 days after the initiation of corticosteroids for fetal lung maturation compared with women without a short cervical length.

Cervical length in adolescents versus adults

Purpose: Two of the known risk factors for spontaneous preterm birth (sPTB) are short cervical length (CL) ≤ 25 mm and adolescence (≤19 years). Our objective was to evaluate whether adolescent women have a higher incidence of short CL compared to their 20–24 year old counterparts.Materials and methods: Retrospective cohort of nulliparous singleton gestations undergoing universal second trimester transvaginal ultrasound (TVU) CL screening between January 2012 and June 2013. Adolescent women ≤19 years of age were compared to women 20–24 years of age. Primary outcomes were mean CL and incidence of CL ≤25 mm. Secondary outcomes were incidence of PTB <37 weeks, delivery mode, birth weight, and NICU admission.Results: One hundred and five adolescents and 236 women 20–24 years underwent TVU CL screening. There was no difference in mean CL (40.6 mm vs. 40.6 mm, p = 0.51) or incidence of CL ≤25 mm (1.0% vs. 1.7%; OR 0.56 [0.06–5.1]). After controlling for maternal differences, there still was no significant correlation between maternal age and CL. There was no significant difference in PTB, birth weight, or NICU admission between the groups. CL measurements did not significantly differ across all maternal ages (14–42 years).Conclusions: There is no difference in mean CL or incidence of CL ≤25 mm among adolescents compared to women 20–24 years.

Diverse outcome following early prenatal diagnosis of pulmonary stenosis.

To assess the natural history and outcome of fetal pulmonary stenosis (PS), particularly that detected at 14-17 weeks' gestation. In this retrospective study we searched an electronic database of women from the general Israeli population attending a private ultrasound institute (Al-Kol ultrasound institute in Haifa) for routine complete early fetal ultrasound, including all fetal systems and a fetal echocardiogram, between 2004 and 2015. Ninety-seven percent of the women were at low risk of fetal malformations, and 3% had risk factors such as maternal Type-1 diabetes mellitus, exposure during pregnancy to teratogenic drugs, or anomalies in previous pregnancies or in other family members. At presentation at 14-17 weeks of gestation, color and pulsed Doppler imaging were performed across the four cardiac valves. We identified cases in which abnormal flow was detected, leading to suspicion of PS; in these cases, a follow-up examination was carried out at 17-19 weeks and then monthly until delivery or resolution of the finding, and postnatal echocardiography was performed at birth, 4-6 weeks thereafter, and yearly afterwards. Outcome data for suspicious cases, including postnatal diagnosis and general or specific symptoms, were collected by contacting the parents via email or telephone. Among 24 185 early prenatal transvaginal ultrasound screening examinations, 23 cases of suspected PS were identified. They were classified into three groups, according to their ultrasound findings. In Group A (n = 8), the ultrasound screen was normal except for high flow velocity across the pulmonary valve. In six cases, this finding had resolved by 20-21 weeks of gestation and all were found to be normal at postnatal follow-up, one case underwent termination of pregnancy at 19 weeks and PS was confirmed at autopsy and one case was lost to follow-up. In Group B (n = 12), there was aliasing across the pulmonary valve. Two of these cases were normal postnatally and eight had mild-to-moderate PS; the remaining two cases developed hypoplastic right ventricle and pulmonary atresia at 19-20 weeks and the pregnancies were terminated. In Group C (n = 3) PS was associated with other anomalies; all three pregnancies were terminated. There were an additional six cases (Group D) not identified in early gestation, in which PS was late-onset. One had tricuspid regurgitation at the early screen, but was subsequently diagnosed with Ebstein's anomaly and pulmonary atresia, at 22 weeks, and was terminated. The other cases had completely normal early ultrasound screening examinations: one case had Ebstein's anomaly and PS was diagnosed at birth; four had isolated mild PS, of which one was diagnosed at 22 weeks' gestation and the other three were diagnosed postnatally, before 3 months of age. The sensitivity for detection of the ascertained cases of PS was 64% (11/17) and the specificity was > 99%. There is a diverse spectrum of presentation of fetal PS in the early mid-trimester. A possible explanation for this could be different pathophysiological pathways. Further study is needed to explain the different prenatal sonographic presentations in an unselected population. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.

Abstract CT104: Ovarian cancer screening and mortality in the UK collaborative trial of ovarian cancer screening (UKCTOCS): A randomised controlled trial

Abstract Background: Ovarian cancer has poor prognosis, with 60% of patients dying within 5 years. Early detection of ovarian cancer through blood tests may reduce mortality through detection earlier in the disease process than occurs with clinical detection. Since survival time in screening trials is measured from time of randomization rather than diagnosis as is done in therapeutic trials, there is a well established delayed effect of screening. The impact on prevalent cases, women with undiagnosed disease at study entry, is likely to be less than for disease arising after start of screening. One intervention arm of this trial was designed to establish the effect of early detection by screening with blood tests on ovarian cancer mortality. We estimated its impact on cases arising after screening begins (pre-specified) and accounting for the delayed effect (post-hoc). Methods: We recruited postmenopausal women aged 50-74 years from 13 centres in the UK and randomly allocated participants to annual multimodal screening (MMS) with serum CA125 interpreted with use of the risk of ovarian cancer algorithm, annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. The primary outcome was death due to ovarian cancer by Dec 31, 2014, comparing MMS with no screening. All analyses were by modified intention to screen, excluding the small number of women we discovered after randomisation to have a bilateral oophorectomy, have ovarian cancer, or had exited the registry before recruitment. For this report, we focused on the impact of screening on cases arising after the randomization in the MMS arm where we excluded cases arising prior to randomization, and on the delayed effect for which we applied the weighted log-rank test with weights which increased over time to account for the delayed effect. Results: For the MMS comparison, we randomly allocated 202 638 women: 50 640 (25.0%) to MMS, and 101 359 (50.0%) to no screening. More than 99.9% women were eligible for analysis. Screening ended on Dec 31, 2011, and included 345 570 MMS annual screening episodes. At a median follow-up of 11.1 years, we diagnosed ovarian cancer in 968 women: 338 in the MMS group, and 630 in the no screening group. Of these women, 148 (0.29%) women in the MMS group, and 347 (0.34%) in the no screening group had died of ovarian cancer. A standard Cox proportional hazards model, which does not account for the delayed effect nor for the lesser impact on prevalent cases gave a mortality reduction over years 0-14 of 15% (95% CI -3 to 30; p = 0.10) with MMS. However, the pre-specified analysis of death from ovarian cancer of MMS versus no screening with exclusion of prevalent cases showed significantly different death rates (p = 0.021), with an overall average mortality reduction of 20% (-2 to 40) and a reduction of 8% (-27 to 43) in years 0-7 and 28% (-3 to 49) in years 7-14 in favor of MMS. The post-hoc weighted log-rank test had a significant p-value of 0.023 with weights equal to ovarian cancer mortality pooled over the MMS and control arms. Conclusion: Accounting for the delayed effect of screening and estimating the impact excluding prevalent cases yielded a significant but delayed impact of MMS screening in years 7-14. Further follow-up is needed however before firm conclusions can be reached on the efficacy of ovarian cancer screening. Citation Format: Ian J. Jacobs, Usha Menon, Andy Ryan, Aleksandra Gentry-Maharaj, Matthew Burnell, Jatinderpal K. Kalsi, Alistair J. McGuire, Mahesh Parmar, Steven J. Skates. Ovarian cancer screening and mortality in the UK collaborative trial of ovarian cancer screening (UKCTOCS): A randomised controlled trial. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr CT104.

Can Screening Reduce Mortality from Ovarian Cancer

To determine whether screening is effective at reducing mortality from ovarian cancer, investigators in the U.K. randomized >200,000 postmenopausal women (age range, 50–74; mean age at baseline, 61) to no screening, annual transvaginal ultrasound screening (TVUS), or annual multimodal screening (MMS) with serum CA125 using the Risk of Ovarian Cancer Algorithm (ROCA), which takes into account temporal changes in CA125 levels. Women assessed as normal risk by ROCA criteria were advised to undergo …

Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial

SummaryBackgroundOvarian cancer has a poor prognosis, with just 40% of patients surviving 5 years. We designed this trial to establish the effect of early detection by screening on ovarian cancer mortality.MethodsIn this randomised controlled trial, we recruited postmenopausal women aged 50–74 years from 13 centres in National Health Service Trusts in England, Wales, and Northern Ireland. Exclusion criteria were previous bilateral oophorectomy or ovarian malignancy, increased risk of familial ovarian cancer, and active non-ovarian malignancy. The trial management system confirmed eligibility and randomly allocated participants in blocks of 32 using computer-generated random numbers to annual multimodal screening (MMS) with serum CA125 interpreted with use of the risk of ovarian cancer algorithm, annual transvaginal ultrasound screening (USS), or no screening, in a 1:1:2 ratio. The primary outcome was death due to ovarian cancer by Dec 31, 2014, comparing MMS and USS separately with no screening, ascertained by an outcomes committee masked to randomisation group. All analyses were by modified intention to screen, excluding the small number of women we discovered after randomisation to have a bilateral oophorectomy, have ovarian cancer, or had exited the registry before recruitment. Investigators and participants were aware of screening type. This trial is registered with ClinicalTrials.gov, number NCT00058032.FindingsBetween June 1, 2001, and Oct 21, 2005, we randomly allocated 202 638 women: 50 640 (25·0%) to MMS, 50 639 (25·0%) to USS, and 101 359 (50·0%) to no screening. 202 546 (>99·9%) women were eligible for analysis: 50 624 (>99·9%) women in the MMS group, 50 623 (>99·9%) in the USS group, and 101 299 (>99·9%) in the no screening group. Screening ended on Dec 31, 2011, and included 345 570 MMS and 327 775 USS annual screening episodes. At a median follow-up of 11·1 years (IQR 10·0–12·0), we diagnosed ovarian cancer in 1282 (0·6%) women: 338 (0·7%) in the MMS group, 314 (0·6%) in the USS group, and 630 (0·6%) in the no screening group. Of these women, 148 (0·29%) women in the MMS group, 154 (0·30%) in the USS group, and 347 (0·34%) in the no screening group had died of ovarian cancer. The primary analysis using a Cox proportional hazards model gave a mortality reduction over years 0–14 of 15% (95% CI −3 to 30; p=0·10) with MMS and 11% (−7 to 27; p=0·21) with USS. The Royston-Parmar flexible parametric model showed that in the MMS group, this mortality effect was made up of 8% (−20 to 31) in years 0–7 and 23% (1–46) in years 7–14, and in the USS group, of 2% (−27 to 26) in years 0–7 and 21% (−2 to 42) in years 7–14. A prespecified analysis of death from ovarian cancer of MMS versus no screening with exclusion of prevalent cases showed significantly different death rates (p=0·021), with an overall average mortality reduction of 20% (−2 to 40) and a reduction of 8% (−27 to 43) in years 0–7 and 28% (−3 to 49) in years 7–14 in favour of MMS.InterpretationAlthough the mortality reduction was not significant in the primary analysis, we noted a significant mortality reduction with MMS when prevalent cases were excluded. We noted encouraging evidence of a mortality reduction in years 7–14, but further follow-up is needed before firm conclusions can be reached on the efficacy and cost-effectiveness of ovarian cancer screening.FundingMedical Research Council, Cancer Research UK, Department of Health, The Eve Appeal.