Cervical cerclage vs cervical pessary in women with cervical insufficiency: A multicentric, open-label, randomised, controlled pilot trial [the CEPEIC trial].

Objective: Cervical insufficiency accounts for 8 % of preterm births. Pessary and cerclage are considered preventive approaches for preterm birth. These interventions were compared in terms of reducing the prematurity rate in women with previous preterm birth, due to cervical insufficiency or due to having a short cervix in their current pregnancy. Methods: This was a prospective, multicentric, open-label, randomised, pilot, controlled trial. Participants were women with singleton pregnancies who had previous preterm birth caused by cervical insufficiency or previous preterm birth and a short cervix [≤ 25 mm] in their current pregnancy. Women were randomised [1:1] to either cerclage or pessary. The primary outcome was to assess the feasibility of a trial on cervical pessary vs. cerclage to prevent preterm birth before 34 weeks in women with cervical insufficiency. As a secondary outcome, we studied the morbidity rate of the pessary versus the cerclage in women with cervical insufficiency and assessed the financial impact of using both devices in these women. The sample size was calculated based on the estimated population that we could potentially recruit: 60 women, 30 for each group, to ascertain whether the rate of preterm birth < 34 weeks of gestation may be reduced from 34 % to at least 27 % in the pessary group, as in the results obtained with the cerclage. Results: No significant differences in preterm birth < 34 weeks of gestation were observed in our study, although it was underpowered to detect these differences [the relative risk [RR] of PB < 34 weeks of gestation was 0.8 [95 % CI: 0.31-2.09, p = 0.888]. The rates of obstetric and perinatal complications were similar for both devices [15 cases in both groups, 50 % of cases [RR; 0.6-1.68; p = 1]. Cervical pessary had fewer secondary effects than the cerclage [less bleeding at insertion in the pessary group compared with cerclage, 1 case vs 14 cases, p < 0.001; less pain at removal in the pessary group compared with cerclage, 14 vs 22 cases. p = 0.042 and less bleeding, 2 cases vs. 10 cases, p = 0.027]. Conclusions: Pessary does not seem less effective than cerclage, although these findings need to be confirmed in a larger randomised controlled trial. Pessary had fewer secondary effects than cerclage both at insertion and removal. Sinopsis: Cervical pessary does not seem to be less effective than cerclage. Cervical pessary had fewer secondary effects than cerclage.

Intraobserver and interobserver variability in first-trimester transvaginal ultrasound cervical length.

Objectives: To determine intraobserver and interobserver variability in the measurement of different cervical length (CL) components at the first trimester (endocervical canal and isthmus), describe the optimum measurement method (single line or two lines) and establish a normality curve of first trimester CL in our population.Methods: Women who attended the first-trimester US scan, between 11.0 and 13.6 weeks of gestation at Vall d'Hebron Universitary Hospital, Barcelona, Spain were included. Inclusion criteria were singleton pregnancies in women over 18 years of age, no gestational complications, uterine malformations or uterine surgery. Lengths of the endocervical canal and uterine isthmus were measured using two methods.Results: Both methods for endocervical canal measurement, single line and two lines, showed low intraobserver variability between examiners, with no statistical differences in the majority of measurements. A correct correlation existed between examiners using the single-line two-line measurements, with a concordance correlation coefficient of 0.76.Conclusions: Cervical length in the first trimester was reproducible for the same physician and between different physicians; however, it is essential to ensure examiners receive adequate training in the technique.

Suitability of open-field autorefractors as pupillometers and instrument design effects.

AIM: To determine the agreement and repeatability of the pupil measurement obtained with VIP-200 (Neuroptics), PowerRef II (Plusoptix), WAM-5500 (Grand Seiko) and study the effects of instrument design on pupillometry. METHODS: Forty patients were measured twice in low, mid and high mesopic. Repeatability was analyzed with the within-subject standard deviation (Sw) and paired t-tests. Agreement was studied with Bland-Altman plots and repeated measures ANOVA. Instrument design analysis consisted on measuring pupil size with PowerRef II simulating monocular and binocular conditions as well as with proximity cues and without proximity cues. RESULTS: The mean difference (±standard deviation) between test-retest for low, mid and high mesopic conditions were, respectively: -0.09 (±0.16), -0.05 (±0.18) and -0.08 (±0.23) mm for Neuroptics, -0.05 (±0.17), -0.12 (±0.23) and -0.17 (±0.34) mm for WAM-5500, -0.04 (±0.27), -0.13 (±0.37) and -0.11 (±0.28) mm for PowerRef II. Regarding agreement with Neuroptics, the mean difference for low, mid and high mesopic conditions were, respectively: -0.48 (±0.35), -0.83 (±0.52) and -0.38 (±0.56) mm for WAM-5500, -0.28 (±0.56), -0.70 (±0.55) and -0.61 (±0.54) mm for PowerRef II. The mean difference of binocular minus monocular pupil measurements was: -0.83 (±0.87) mm; and with proximity cues minus without proximity cues was: -0.30 (±0.77) mm. CONCLUSION: All the instruments show similar repeat-ability. In all illumination conditions, agreement of Neuroptics with WAM-5500 and PowerRef II is not good enough, which can be partially induced due to their open field design.

Modification of cervical length after cervical pessary insertion: correlation weeks of gestation.

OBJECTIVES: To observe the modifications in cervical length (CL) in patients with and without cervical pessary (Arabin® ASQ 65/25/32) and correlate these modifications with gestational age at delivery. STUDY DESIGN: Prospective study of asymptomatic singleton pregnancies (PECEP-Trial) between weeks 20 + 0 and 23 + 6 with maternal short cervix (<25 mm) randomised into two groups: expectant management and cervical pessary. RESULTS: This study included 380 pregnant women: 190 with pessary and 190 without pessary. Mean CL in both groups at the time of randomisation showed no statistically-significant differences (pessary group: 19.0 mm and management group: 19.0 mm; p = 0.9). Mean CL measured after randomisation was 15.4 mm in patients of the expectant management group and 21.5 mm in the pessary group. These differences were statistically significant (p < 0.0001). When means at randomisation and at the second measurement were compared, CL had decreased by 3.6 mm in the expectant management group and increased by 2.6 mm in the pessary group; this difference was statistically significant (p < 0.0001). Coefficients of correlation showed that among patients of both groups with the same CL at 20 weeks of gestation, those with a pessary gave birth later. CONCLUSIONS: Insertion of an Arabin cervical pessary increased CL in asymptomatic patients with a short cervix, which correlated with shorter gestational age at delivery. The cervical pessary halted the progressive decrease in CL, which correlated with longer gestational age at delivery.

Predictors of obstetric complications in women with heart disease.

OBJECTIVES: The objective of this study is to evaluate obstetric outcomes in women with heart disease and determine whether current multidisciplinary management approaches adversely affect the mother, the neonate, or both. Also to compare the accuracy of several risk scores (RS) including the modified World Health Organization classification (mWHO) and CARPREG to predict obstetric and neonatal complications and to study the addition value of Uteroplacental-Doppler flow (UDF) parameters to predict obstetric complications. METHODS: A prospective cohort study examined outcomes in women with heart disease (HD), the majority of whom had corrective surgery and delivered between January 2007 and March 2012. RESULTS: One hundred and seventy-four patients with 179 pregnancies were included in the study. Obstetric complications, including premature labor, arose in 87 patients (48.6%). Neonatal complications were observed in 11 cases (7%). On multivariate analysis, maternal heart disease was predictive of adverse perinatal events (46 cases, 25.7%) and mode of delivery (Thierry's spatula) of third- or fourth-degree perineal tears (six cases, 3.2%). mWHO classification predicted obstetric complications (p = 0.0001) better than the CARPREG study. Impaired UDF (uterine artery pulsatility index-20 weeks and umbilical artery pulsatility index-32 weeks in HD versus healthy women: 20w 1.12 versus 1.34, p = 0.005; 32w 0.87 versus 1.09, p = 0.008) was associated with adverse obstetric and offspring outcome in the group of HD pregnant women. CONCLUSIONS: Nearly 50% of pregnancies were associated with an adverse obstetric outcome, particularly IUGR. mWHO was better at predicting obstetric and neonatal complications that CARPREG in all categories. Furthermore, compromised UDF combined with mWHO improved the prediction of obstetric and offspring complications in this population.

Surgery improves breast cancer-specific survival in octogenarians with early-stage breast cancer.

INTRODUCTION: No consensus exists on optimum therapy for older cancer patients. This singlecentre study was conducted to review the treatment and outcomes for octogenarian women treated for breast cancer. METHODS: Data of all elderly breast cancer patients (≥80 years) with primary breast cancer treated at out institution between 1990 and 2009. Patients with carcinoma in-situ (stage 0) and advanced breast cancer (stage IV) were excluded. Breast cancer-specific survival and disease-free survival for the different patient groups were analysed according to the Kaplan-Meier method. RESULTS: The study population consisted of 259 patients (median age 84 years). There were 189 (73%) patients with early stage disease (I, IIA, IIB) and 70 (27%) with locally advanced disease (IIIA, IIIB, IIIC). A total of 175 (67.7%) patients underwent surgical treatment and 84 (32.4%) received primary endocrine treatment. Patients were followed for a median of 65 months. In patients with early stages, the mean breast cancer-specific survival was 108 months (95% CI 101-115) in the surgical group and 50 months (95% CI 39-61) in the non-surgical group (P < 0.01), whereas patients with locally advanced breast cancer breast cancer-specific survival was similar for the surgical and non-surgical groups. Breast cancer-specific survival and disease-free survival were significantly better among patients who underwent standard surgical treatment than among those with suboptimal surgery. CONCLUSION: In women ≥80 years with early-stage breast cancer, standard surgical treatment as compared with non-surgical therapy was associated with a better breast cancer-specific.