A multi-centre, open-label, prospective, observational study to assess the safety of a nifedipine oral solution in the treatment of preterm labor / Estudio multicéntrico, de diseño abierto, prospectivo y observacional para evaluar la seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro

Objective: To analyze the safety profile of a nifedipine oral solution in the treatment of preterm labor (PTL). Methods: A multi-center, open-label, prospective, single-arm, observational study was conducted in 500 women with PTL to whom a nifedipine oral solution was prescribed according to its Summary of Product Characteristics. Safety profile and tolerability of oral administration of nifedipine solution during routine clinical practice was assessed as the primary objective of the study and treatment efficacy as secondary objective. Results: No severe adverse events were reported among these women, including severe hypotension. Eight patients (2.3%) reported adverse reactions of moderate intensity, and in 0.9% of the patients (3 cases), these adverse reactions caused the discontinuation of the treatment. Conclusions: The results of this study show that nifedipine oral solution exhibits an excellent safety profile used as a tocolytic treatment in women with PTL.(AU)

Objetivo: Analizar el perfil de seguridad de una solución oral de nifedipino en el tratamiento del parto prematuro (PP). Métodos: Se llevó a cabo un estudio observacional, prospectivo, de diseño abierto, de rama única y multicéntrico en 500 mujeres que presentaban un PP, a las que se les administró una solución oral de nifedipino según la ficha técnica del producto. El perfil de seguridad y la tolerancia de la solución oral de nifedipino, en el contexto de la práctica clínica rutinaria, fueron evaluados como objetivo primario del estudio, y la eficacia del tratamiento, como objetivo secundario. Resultados: No se notificaron efectos adversos graves, incluyendo hipotensión severa. Ocho pacientes (2,3%) presentaron reacciones adversas de intensidad moderada, y en el 0,9% de las pacientes (3 casos) estos efectos adversos provocaron la discontinuación del tratamiento. Conclusiones: Los resultados de este estudio muestran que la solución oral de nifedipino dispone de un excelente perfil de seguridad para su uso como tocolítico en el tratamiento de mujeres con PP.(AU)

Cervical consistency index and risk of Cesarean delivery after induction of labor at term.

OBJECTIVE: To evaluate the association between the cervical consistency index (CCI) and the risk of Cesarean delivery after planned induction of labor (IOL) at term. METHODS: This was a prospective observational study of women with a term singleton pregnancy admitted for IOL due to maternal or fetal indication. Ultrasonographic images were obtained before IOL and CCI was calculated offline once recruitment was completed. The main outcome was defined as Cesarean delivery due to failed IOL or arrest of labor. Cesarean deliveries indicated due to maternal or fetal compromise (Van Dillen's grade 1 or 2) were excluded from analysis. Univariate statistical analysis was performed using Fisher's exact test and Student's t-test for categorical and continuous variables, respectively. Multivariate analysis was performed using logistic regression, including CCI and other variables related to the main outcome. Intraclass correlation coefficients were used to estimate intra- and interobserver agreement. RESULTS: Of 510 women admitted for IOL during the study period and for whom image quality was adequate, 46 were excluded due to emergency Cesarean delivery leaving 464 pregnancies for analysis. Cesarean section due to failed IOL or arrest of labor was performed in 100/464 (21.6%) pregnancies. The mean CCI of women who underwent Cesarean delivery was not significantly different from that in those who had vaginal delivery after IOL (70.1 ± 12.3% vs 70.0 ± 13.1%; P = 0.94). Multivariate analysis also showed absence of statistical association between CCI and Cesarean delivery for failed IOL or arrest of labor. Intraclass correlation coefficients for intra- and interobserver agreement were 0.81 (95% CI, 0.66-0.89) and 0.86 (95% CI, 0.75-0.92), respectively. CONCLUSION: CCI does not seem to be associated with the risk of Cesarean delivery after IOL. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.

Mid-trimester sonographic cervical consistency index to predict spontaneous preterm birth in a low-risk population.

OBJECTIVES: To investigate the effectiveness of mid-trimester sonographic cervical consistency index (CCI) for the prediction of spontaneous preterm birth (sPTB) in low-risk pregnancies and to compare its performance with that of mid-trimester sonographic cervical-length (CL) measurement. METHODS: This was a prospective cohort study of women with a singleton pregnancy examined by ultrasound at 19 + 0 to 24 + 6 weeks' gestation. All women underwent transvaginal ultrasound examination of the cervix, but CCI and CL were measured, offline, only in women without a risk factor for sPTB. Staff and participants were blinded to CL and CCI results. CCI was obtained by calculating the ratio between the anteroposterior diameter of the uterine cervix at maximum compression and at rest. The primary outcome was prediction of sPTB before 37 + 0 weeks. Receiver-operating characteristics (ROC) curves were produced and sensitivity and specificity were calculated for the optimal cut-off based on the ROC curve and for the 1st , 5th and 10th centiles of CCI and CL. Intraclass correlation coefficients (ICC) and Bland-Altman plots were used to estimate intra- and interobserver agreement and reliability for measurement of CCI and CL. RESULTS: Of the 749 women who underwent ultrasound examination of the cervix, 532 were included for analysis. The rates of sPTB before 37 + 0 and before 34 + 0 weeks were 4.1% (22/532) and 1.3% (7/532), respectively. The rates of short cervix < 25 mm and ≤ 20 mm were 0.9% (5/532) and 0.4% (2/532), respectively. The area under the ROC curve (AUC) with regard to predicting sPTB before 37 + 0 weeks was 0.84 (95% CI, 0.75-0.93) for CCI compared with 0.68 (95% CI, 0.56-0.81) for CL (P = 0.03). The optimal cut-off based on the ROC curve was 64.6% for CCI (sensitivity, 77.3%; specificity, 82.7%) and that for CL was 37.9 mm (sensitivity, 72.7%; specificity, 61.2%). The AUC with regard to predicting sPTB before 34 + 0 weeks was 0.87 (95% CI, 0.71-1.0) for CCI compared with 0.71 (95% CI, 0.47-0.94) for CL (P = 0.25). The optimal cut-off based on the ROC curve was 63.6% for CCI (sensitivity, 85.7%; specificity, 84.0%) and that for CL was 37.9 mm (sensitivity, 85.7%; specificity, 61.3%). Intraobserver ICC was > 0.90 both for CCI and CL, while interobserver ICC was 0.89 for CCI and 0.90 for CL. CONCLUSIONS: Second-trimester CCI is a better predictor of sPTB < 37 weeks in low-risk pregnancies than is CL. External validation is needed as well as studies assessing the value of CCI as a screening tool in unselected and high-risk populations. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Primary management of operable breast cancer by minimal surgery and radiotherapy.

109 cases of breast cancer were treated by tumorectomy and radiotherapy or radiotherapy alone. Almost 30% with small tumors (T1, T2) were considered inoperable for medical reasons and 70% refused mastectomy. Over the past five years the number of patients refusing mastectomy has definitely increased. 59 cases of surgically resectable cancers (T1, T2, T3, N0, N1) had a minimum followup of two years (average 4 years +/- 3 months). Absolute and determinate survivals NED were 65% and 86%. There were four local recurrences (8%). Secondary mastectomy could be performed on three. Microscopic involvement of the surgical margin by cancer did not alter the local control rate. The cosmetic results were good in 98%. Gross removal of the tumor followed by radiotherapy may be offered as an alternative to mastectomy in patients with operable breast cancer.