Cost-effectiveness of universal routine sonographic cervical-length measurement at 19 to 25 weeks' gestation.

BACKGROUND: National second-trimester scanning of cervical length was introduced in Israel in 2010, and in the decade thereafter, a significant systematic reduction in preterm birth and in the delivery of low birthweight babies was found among singletons. OBJECTIVE: In this study, we sought to estimate the cost-effectiveness of a national policy mandating second-trimester cervical length screening by ultrasound, followed by vaginal progesterone treatment for short cervical length in comparison with no screening strategy. STUDY DESIGN: We constructed a decision model comparing 2 strategies, namely (1) universal cervical length screening, and (2) no screening strategy. This study used the national delivery registry of Israel's Ministry of Health. All women diagnosed with a second-trimester cervical length <25 mm were treated with vaginal progesterone and were monitored with a bimonthly ultrasound scan for cervical dynamics and threat of early delivery. Preterm birth prevalence associated with short cervical length, the efficacy of progesterone in preterm birth prevention, and the accuracy of cervical length measurements were derived from previous studies. The cost of progesterone and bimonthly sonographic surveillance, low birthweight delivery, newborn admission to intensive care units, the first-year costs of managing preterm birth and low birthweight, and instances of handicaps and the cost of their follow-up were extracted from the publicly posted registry of Israel's Ministry of Health and Israel Social Securities data. Monte Carlo simulations decision tree mode, Tornado diagrams, and 1- and 2-way sensitivity analyses were implemented and the base case and sensitivity to parameters that were predicted to influence cost-effectiveness were calculated. RESULTS: Without cervical length screening, the discounted quality-adjusted life years were 30.179, and with universal cervical length screening, it increased to 30.198 (difference of 0.018 quality-adjusted life years). The average cost of no screening for cervical length strategy was $1047, and for universal cervical length screening, it was reduced to $998. The calculated incremental cost-effectiveness ratio was -$2676 per quality-adjusted life year (dividing the difference in costs by the difference in quality-adjusted life years). Monte Carlo simulation of cervical length screening of 170,000 singleton newborns (rounded large number close to the number of singleton newborns in Israel) showed that 95.17% of all babies were delivered at gestational week ≥37 in comparison with 94.46% of babies with the no screening strategy. Given 170,000 singleton births, the national savings of screening for short cervical length when compared with no cervical length screening amounted to $8.31M annually, equating to $48.84 for a base case, and the incremental cost-effectiveness ratio for each case of low birthweight or very low birthweight avoided was -$14,718. A cervical length <25 mm was measured for 30,090 women, and of those, 24,650 were false positives. The major parameters that affected the incremental cost-effectiveness ratio were the incidence of preterm birth, the specificity of cervical length measurements, and the efficacy of progesterone treatment. At a preterm birth incidence of <3%, universal screening does not lead to a cost saving. CONCLUSION: National universal cervical length screening should be incorporated into the routine anomaly scan in the second trimester, because it leads to a drop in the incidence of preterm birth and low birthweight babies in singleton pregnancies, thereby saving costs related to the newborn and gaining quality-adjusted life years.

[MATERNAL SERUM ANGIOGENIC FACTORS AS AN AIDING TOOL FOR SCREENING WOMEN WITH SUSPECTED PREECLAMPSIA NEAR DELIVERY - INITIAL DATA AND AN ESTIMATED COST-BENEFIT].

INTRODUCTION: Preeclampsia (PE) is a major pregnancy complication, posing considerable morbidity and mortality. The maternal serum angiogenic factors - PlGF and sFlt-1, and their ratio appear to be promising markers to predict PE. Aims: To assess whether the evaluation of PlGF and sFlt-1 adds to the clinical workup of women with suspected PE, and to estimate the cost/benefit. METHODS: We prospectively enrolled pregnant women with suspected PE who were admitted to the Maternal-Fetal Medicine Unit (MFM) at Shamir Medical Center. Pregnancy and delivery records were collected from their computerized electronic medical records. PlGF<150pg/ml and sFlt-1/PlGF>38 measured prospectively were used to predict PE. RESULTS: Of 105 women included, 28 were in the control group with unrelated complications and none developed PE. Among 66 women with suspected PE, 27(41%) developed the syndrome, with a positive predictive value (PPV) of 90.3% for PlGF<150 pg/ml and 88.9% for sFlt-1/PlGFabove 38. Out of 11 women with suspected intrauterine growth restriction (IUGR), six developed the syndrome, and among them, the negative predictive value (NPV) was ~ 90%. CONCLUSIONS: Angiogenic factors are reliable in predicting PE near delivery. Of 8355 annual deliveries, 584 were admitted for suspected PE. The annual test cost was NIS 66,576 (NIS 140 per single test). Cost-saving was NIS 2.18 million, the ratio of cost saved vs. test cost was 32.7. DISCUSSION: The angiogenic factors are efficient and cost-saving in PE prediction near delivery. A larger study is necessary to determine the inclusion of angiogenic factors in the workup for suspected PE.

Tubal patency assessment using sequential transvaginal ultrasound and hysterosalpingo-foam sonography after methotrexate treatment for tubal pregnancy.

RESEARCH QUESTION: What is the efficacy of sequential two-dimensional transvaginal ultrasound (2D-US) and hysterosalpingo-foam sonography (HyFoSy) after methotrexate (MTX) treatment for tubal pregnancy among patients who desire a future pregnancy? DESIGN: A prospective trial conducted between May 2019 and November 2020. Patients who had a suspected tubal ectopic pregnancy diagnosed by ultrasound and treated by MTX were included. These patients underwent sequential transvaginal 2D-US assessment of the pelvic organs and a complementary HyFoSy for tubal patency. The primary outcome was tubal obstruction in the affected side. RESULTS: A total of 360 women underwent sequential transvaginal 2D-US assessment of the pelvic organs and a complementary HyFoSy for tubal patency. Of these, 40 (11.1%) women fulfilling the inclusion criteria were enrolled. In six out of 40 (15%), hydrosalpinx of the affected tube was found during the initial transvaginal ultrasound examination and were excluded from further investigation. In the remaining 34 (85%) patients, HyFoSy was carried out. Tubal block was found in 10 out of 34 (29.4%) patients. Of these, eight out of 34 (23.5%) and two out of 34 (5.9%) had a proximal block of the affected tube and bilateral proximal obstruction, respectively. Hysterosalpingography confirmed the tubal obstruction in all the affected cases. No procedure-related complications were documented. CONCLUSIONS: Forty per cent of women who were treated by MTX for tubal pregnancy were diagnosed with tubal obstruction. We recommend that sequential transvaginal ultrasound and HyFoSy become part of routine follow-up for these women, thus offering them timely referral to the appropriate specialist.

Impact of the COVID-19 Pandemic on Excess Perinatal Mortality and Morbidity in Israel.

OBJECTIVE: The 2020 COVID-19 pandemic has been associated with excess mortality and morbidity in adults and teenagers over 14 years of age, but there is still limited evidence on the direct and indirect impact of the pandemic on pregnancy. We aimed to evaluate the effect of the first wave of the COVID-19 pandemic on obstetrical emergency attendance in a low-risk population and the corresponding perinatal outcomes. STUDY DESIGN: This is a single center retrospective cohort study of all singleton births between February 21 and April 30. Prenatal emergency labor ward admission numbers and obstetric outcomes during the peak of the first COVID-19 pandemic of 2020 in Israel were compared with the combined corresponding periods for the years 2017 to 2019. RESULTS: During the 2020 COVID-19 pandemic, the mean number of prenatal emergency labor ward admissions was lower, both by daily count and per woman, in comparison to the combined matching periods in 2017, 2018, and 2019 (48.6 ± 12.2 vs. 57.8 ± 14.4, p < 0.0001 and 1.74 ± 1.1 vs. 1.92 ± 1.2, p < 0.0001, respectively). A significantly (p = 0.0370) higher rate of stillbirth was noted in the study group (0.4%) compared with the control group (0.1%). All study group patients were negative for COVID-19. Gestational age at delivery, rates of premature delivery at <28, 34, and 37 weeks, pregnancy complications, postdate delivery at >40 and 41 weeks, mode of delivery, and numbers of emergency cesarean deliveries were similar in both groups. There was no difference in the intrapartum fetal death rate between the groups. CONCLUSION: The COVID-19 pandemic stay-at-home policy combined with patient fear of contracting the disease in hospital could explain the associated higher rate of stillbirth. This collateral perinatal damage follows a decreased in prenatal emergency labor ward admissions during the first wave of COVID-19 in Israel. KEY POINTS: · Less obstetrical ER attendance is observed during the pandemic.. · There is a parallel increase in stillbirth rate.. · Stillbirth cases tested negative for COVID-19.. · Lockdown and pandemic panic are possible causes..

[USING MATERNAL SERUM PLACENTAL GROWTH FACTOR (PLGF) FOR RULING OUT PREECLAMPSIA NEAR DELIVERY: PRELIMINARY RESULTS AND ECONOMIC IMPLICATIONS IN ISRAEL].

INTRODUCTION: Preeclampsia (PE) is a major obstetric complication affecting 3-5% of pregnancies and a major contributor to fetal and maternal morbidity and mortality. The level of placental growth factor (PLGF) >150pg/ml in the third trimester was reported to predict PE occurrence within the next 14 days. AIMS: We have conducted a preliminary study among pregnant Israeli women in order to evaluate whether maternal serum PLGF test at admission with suspected PE could rule-out the risk for developing PE. METHODS: We prospectively enrolled pregnant women who were admitted to the high-risk pregnancy department at Shamir Medical Center with suspected PE. The women signed an informed consent form and blood samples were drawn, separated into serum, and taken for PLGF immuno-diagnostic test. All women with suspected PE were managed according to local protocol. The medical staff was blinded regarding PLGF results. All patients' computerized medical records, including developing of PE within 14 days and patients' computerized medical records were collected and a telephone interview was held to verify whether post charging events occurred. RESULTS: Of the 29 women who were enrolled in the study, the group with PLGF<150 pg/ml included 19 women, who had mean PLGF=44.7pg/ml [(95%CI: 6.5-95.3], of which 14 developed PE (positive predictive value 73.7%). There were ten women in the PLGF>150pg/ml group, with mean PLGF=528.7 pg/ml [(95% CI:168-1300, P<0.001)] of which one developed PE (negative predictive value 90%). The sensitivity for ruling out PE by PLGF>150pg/ml was 93%, and the specificity=64.3. CONCLUSIONS: Incorporating blood testing of PLGF into the evaluation triage of pregnant women in Israel who admitted to the delivery clinic with suspected development of PE has generated high efficacy and negative predictive value (NPV) as was previously published Our findings are in accordance with results reported elsewhere but need validation in Israel with larger studies. DISCUSSION: Assuming that at least 7% of ~184,450 (2018) live births in Israel are admitted to the high risk departments for evaluating suspected PE, implementing a PLGF test has a cost-benefit ratio of ~1/8.28 with a cost of NIS 2.52M for test performance of all women attending the delivery clinic with suspected PE over saving NIS 21.37M on unnecessary hospital days.

Prenatal ultrasound charts of orbital total axial length measurement (TAL): a valuable data for correct fetal eye malformation assessment.

OBJECTIVE: To construct prenatal age-specific reference intervals using ultrasound measurement of total axial length (TAL) in normal fetuses for assessing microphthalmia. METHOD: Prospective cross-sectional study of fetuses assessed at a prenatal ultrasound unit between 2011 and 2014. The study cohort comprised 309 pregnant women attending for routine fetal biometry, viability, or anomaly scan between 14 and 41 weeks of gestation. Only singleton viable fetus with normal anatomy, adequate amniotic fluid, accurate gestational age, and no maternal medical complications of pregnancy were enrolled. Biometric measurements were obtained in the axial plane in all the fetuses. Those measurements and the relevant gestational age were registered in a computerized database. RESULTS: A linear growth function was observed between gestational age and bi-orbital diameter (r(2) = 0.95; p < 0.001), ln (TAL) (r2 = 0.89; p < 0.001), OD (r(2) = 0.86; p < 0.001), and IOD (r2 = 0.79; p < 0.001). Tables showing the 5th, 50th, and 95th centiles of orbital parameters were created based on the reference interval charts. CONCLUSIONS: Ultrasound measurement of the fetal TAL ocular distance is feasible. This may assist the multidisciplinary team in the evaluation of fetal eye abnormalities that might be expressed by deviation in TAL.

Assessment of adnexal masses using ultrasound: a practical review.

Pelvic ultrasound is commonly used as part of the routine gynecologic exams, resulting in diagnosis of adnexal masses, the majority of which are functional or benign. However, due to the possible complications involving benign adnexal cysts (ie, adnexal torsion, pelvic pain) and the utmost importance of early diagnosis and treatment of ovarian cancer, the correct ultrasound diagnosis of adnexal masses is essential in clinical practice. This review will describe the typical ultrasound appearance of the common physiologic, benign, and malignant adnexal masses with the aim of aiding the clinician to reach the correct diagnosis.

Assessment of the accuracy of multiple sonographic fetal weight estimation formulas: a 10-year experience from a single center.

OBJECTIVES: The primary aim of this study was to compare the accuracy of sonographic fetal weight estimation models. The secondary aim was to define the most accurate time (4-7 or 3 days before delivery) for evaluating fetal weight. METHODS: In this retrospective cohort study, a total of 12,798 sonographic fetal weight estimations were analyzed, of which 9459 were performed within 3 days of delivery and 3339 within 4 to 7 days. The cohort included all singleton pregnancies recorded at a single medical center from January 2000 to December 2010, with 24 weeks' gestation minimum. Predicted birth weights were calculated according to 23 sonographic fetal weight estimation models; in total, 294,354 sonographic weight estimations were evaluated and compared to the actual birth weights. RESULTS: The accuracy of the models in predicting birth weight differed considerably. The most accurate models used 3 or more fetal measurements followed by models using abdominal circumference only. The models developed by Sabbagha et al (Am J Obstet Gynecol 1989; 160:854-862) proved most accurate, with a mean percent error of -0.2% and greater than 92% of estimates within 15% of birth weight (P < .05). Nineteen sonographic fetal weight estimation models (82.6%) better predicted fetal weight at 4 to 7 days before delivery (P < .001). Twenty-two (95%) of the models were less accurate at the extreme ends of fetal weight. CONCLUSIONS: Different formulas for fetal weight estimation vary greatly; we recommend that each center should evaluate the most accurate formula according to its attending population. Estimation of fetal weight performed 4 to 7 days before delivery using most models was more accurate than estimations performed 3 days before delivery.

Intrapartum measurement of cervical dilatation using translabial 3-dimensional ultrasonography: correlation with digital examination and interobserver and intraobserver agreement assessment.

OBJECTIVE: The purpose of this study was to determine the accuracy and reproducibility of intrapartum translabial 3-dimensional (3D) ultrasonographic measurements of cervical dilatation during labor. METHODS: A prospective observational study was conducted. Three-dimensional ultrasonographic volume data sets from 52 patients were collected during labor and stored. Later, all volumes were randomly reviewed twice offline by 2 examiners blinded to previous clinical and ultrasonographic measurements. The correlation with delivery room personnel digital vaginal examinations and interobserver and intraobserver agreement were determined. RESULTS: Twenty-four patients were examined during the latent phase (0- to 4-cm cervical dilatation), and 28 patients were examined during the active phase (5- to 10-cm cervical dilatation). Translabial 3D ultrasonographic measurements of the cervical mean and maximal diameters and inner cervical area showed a positive correlation with digital vaginal examinations (r(2) = 0.609, 0.587, and 0.469, respectively; all P < .001). The interobserver mean differences +/- SD between paired measurements for the mean and maximal cervical dilatation and inner cervical area were 0.11 +/- 0.49 cm, 0.12 +/- 0.48 cm, and -0.22 +/- 5.69 cm(2), and the intraclass correlation coefficients (ICCs) were 0.82, 0.85, and 0.87. The intraobserver mean differences between paired measurements of the mean and maximal cervical dilatation and inner cervical area were 0.002 +/- 1.15 cm, 0.02 +/- 1.4 cm, and -0.41 +/- 1.15 cm(2), and the ICCs were 0.85, 0.79, and 0.75. CONCLUSIONS: Assessment of cervical dilatation using 3D ultrasonography during labor is feasible and reproducible.