Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial.

OBJECTIVE: To compare the effectiveness of a cervical pessary and vaginal progesterone to prevent spontaneous preterm births in pregnant women with cervical lengths 25 mm or less as measured by transvaginal ultrasonography. METHODS: This was a multicenter, open-label, randomized, noninferiority trial. Women with singleton pregnancies and a short cervix (25 mm or less) measured transvaginally at the second-trimester ultrasonogram were invited to participate. They were computer-randomized (one to one) into cervical pessary placement or treatment with vaginal progesterone (200 mg/24 hours). The primary outcome was spontaneous preterm delivery before 34 weeks of gestation. The noninferiority margin was set at 4% with a 0.025 one-sided α level and a statistical power of 80%. That is, if the 95% CI upper bound exceeded 4%, the pessary could not be deemed noninferior. A sample size of 254 women was required to show noninferiority of the pessary to progesterone. RESULTS: The trial was conducted from August 2012 to April 2016 with the participation of 27 Spanish hospitals. A total of 254 patients were enrolled and 246 included in the intention-to-treat analysis. Demographic and baseline characteristics were similar across groups. The rate of spontaneous delivery before 34 weeks of gestation was 14% (n=18/127) in the pessary group and 14% (n=17/119) in the progesterone group with a risk difference of -0.11% (95% CI -8.85% to 8.62%; P=.99), that is, noninferiority was not shown for the pessary. The incidence of increased vaginal discharge (87% vs 71%, P=.002) and discomfort (27% vs 3%, P<.001) was significantly higher in the pessary group. CONCLUSION: A cervical pessary was not noninferior to vaginal progesterone for preventing spontaneous birth before 34 weeks of gestation in pregnant women with short cervixes. CLINICAL TRIAL REGISTRATION: EU Clinical Trials Register, 2012-000241-13; ClinicalTrials.gov, NCT01643980.

Lymphatic ascites after retroperitoneal lymphadenectomy in gynecologic cancer.

OBJECTIVES: The incidence, diagnosis, treatment and outcome of lymphatic ascites (LA) are studied on 85 consecutive patients with gynecologic cancer who had undergone pelvic and/or paraaortic lymphadenectomy by means of laparotomy or laparoscopy. METHODS: Patients were distributed in two groups depending in the access: Laparoscopy (study group: 44 patients) and laparotomy (control group: 41 patients). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 7, 14, and 28. The main outcome measure was the development of symptomatic or asymptomatic LA. DESIGN: Prospective cohort study. RESULTS: LA developed in 3 patients (6.8%) in the study group and 9 in the control group (22%), with statistical difference (p < 0.05). The relative risk to develop lymphatic ascites after surgery performed by laparotomy was 3.2 (95% CI 1.05-11.07). Mean nodes harvested during the surgery was 18.6 (SD 6.6) in the LA group and 20.4 (SD 9.1) in the group with no LA (p = 0.527). CONCLUSIONS: The incidence of LA after retroperitoneal lymphadenectomy in gynecologic cancer patients is lower in the patients treated by laparoscopy.

Hysteroscopic dynamic assessment of the endometrium in patients treated with long-term tamoxifen.

STUDY OBJECTIVE: To describe the evolutive endometrial hysteroscopic patterns in patients undergoing long-term tamoxifen treatment. DESIGN: Prospective analysis. Analysis of variance test with post hoc Bonferroni test and homogeneity test of percentages were used for hypothesis contrast between the groups. DESIGN CLASSIFICATION: Canadian task force II-2. SETTING: Four Spanish tertiary care hospitals. PATIENTS: A total of 278 patients with breast cancer diagnosed between 2002 and 2004, which completed 5-years adjuvant therapy with tamoxifen. INTERVENTIONS: Ultrasonography and hysteroscopic explorations were performed before starting the treatment and then at yearly intervals during the 5 years of adjuvant treatment. MEASUREMENTS AND MAIN RESULTS: Hysteroscopic endometrial changes were significant throughout the years of treatment. Tamoxifen-exposed endometria present five different patterns: atrophic, cystic, hypervascularized, endometrial polyp, and suspicious of malignancy. Endometrial carcinoma appeared in four patients (1.5%) that bled during the follow-up. CONCLUSION: Tamoxifen produces five different endometrial patterns that evolve dynamically throughout the 5 years of treatment.

Hemodynamic changes during pregnancy and postpartum: a prospective study using thoracic electrical bioimpedance.

OBJECTIVE: To describe hemodynamic changes in normal pregnancy and postpartum by means of thoracic electrical bioimpedance (TEB). METHODS: Eighteen healthy pregnant women were included in the study. Eight different hemodynamic variables were measured by thoracic electrical bioimpedance, from 12th week of gestation until 6th month of postpartum period. Data along pregnancy and postpartum were analyzed with SAS statistical software to compare the different values, so normality curves are reported. RESULTS: Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and peripheral vascular resistances (PVRs) seem to significantly decrease until 24th week of gestation, and then they seem to increase until delivery, recovering normal values gradually during postpartum period. End-diastolic volume (EDV), systolic volume (SV), cardiac output (CO), and ejection fraction (EF) seem to decrease until 48 h after delivery; statistical significance was found. CONCLUSIONS: Thoracic electrical bioimpedance may be the most appropriate and accurate technique to measure normal hemodynamic changes during pregnancy and postpartum.

Valoración ecográfica del endometrio en pacientes tratadas con tamoxifeno / Ultrasonographic endometrial evaluation in patients treated with tamoxifen

Objetivo: Medir el grosor y caracterizar las imágenes ecográficas del endometrio inducidas por tamoxifeno y conocer su evolución durante el tratamiento. Pacientes y métodos: Analizamos 278 pacientes con cáncer de mama, entre 1995 y 2000, en tratamiento adyuvante con tamoxifeno durante 5 años, explorándolas mediante ecografía transvaginal anual. Realizamos un análisis retrospectivo del grosor endometrial y de los patrones morfológicos endometriales reflejados en las imágenes ecográficas archivadas. Resultados: El grosor endometrial aumenta significati-vamente en los años de tratamiento; pasa de 7,84 mm de media el primer año a 16,67 mm el quinto año. Existen 5 patrones ecográficos endometriales en las pacientes tratadas con tamoxifeno: lineal, heterogéneo-hiperrefringente, homogenéneo-hiperrefringente, patrón de pólipo endometrial y patrón sospechoso de malignidad. El primer año predomina el patrón homogéneo-hiperrefringente y el último año, el patrón heterogéneo-hiperrefringente. Conclusiones: El tamoxifeno aumenta el grosor endometrial en los años de tratamiento e induce 5 patrones ecográficos que cambian año a año

Objective: To measure endometrial thickness and characterize ultrasonographic endometrial images induced by tamoxifen, as well as to determine changes in ultrasonographic patterns throughout treatment. Patients and methods: We analyzed 278 patients with breast cancer between 1995 and 2000 under adjuvant therapy with tamoxifen for 5 years. Annual ultrasonographic examination was performed. Endometrial thickness and the morphological endometrial patterns in stored ultrasonographic images were retrospectively analyzed. Results: Endometrial thickness significantly increased during treatment from a mean of 7.84 mm in the first year to 16.67 mm in the fifth year. Five endometrial patterns were found on ultrasonography in patients receiving tamoxifen: linear, heterogeneous-hyperechoic, homogeneous-hyperechoic, endometrial polyp, and suspicious for malignancy. The homogeneous-hyperechoic pattern predominated in the first year and the heterogeneous-hyperechoic pattern in the fifth year. Conclusions: Tamoxifen increases endometrial thickness in the course of treatment and induces five ultrasonographic patterns which change year-by-year

Angiomixoma agresivo vulvar / Aggressive angiomyxoma of the vulva

El angiomixoma agresivo vulvar es una rara entidad que se caracteriza por su agresividad local y por una alta tasa de recurrencia tras su extirpación quirúrgica. Presentamos un caso de angiomixoma agresivo vulvar en una paciente que fue diagnosticada de quiste de Bartholino (AU)

Aggressive angiomyxoma of the vulva is a rare entity characterized by local aggressivity and a high recurrence rate after surgical treatment. We report a case of aggressive angiomyxoma of the vulva in a patient diagnosed with Bartholino’s cyst (AU)

Variables that predict the success of labor induction.

BACKGROUND: To analyze the clinical and sonographic variables that affect the success of labor induction. METHODS: Bishop score, cervical length, and parity were studied in 196 pregnant women in the prediction of successful vaginal delivery within 24 hr of induction. Logistic regression and segmentation analysis were performed. RESULTS: Cervical length [odds ratio (OR) 1.089, P<0.001], Bishop score (OR 0.751, P=0.001), and parity (OR 6.85, P<0.001) predict the success of labor induction. The best cut-off points for cervical length were <16.5, 16.5--27, and >27 mm (P=0.0016). In the analysis of the Bishop score, we also obtained three discriminatory points, 0, 1--4, and >4 (P=0.0006), that best predict the labor induction. Finally, in a global analysis of the variables studied, the best statistic sequence that predicts the labor induction was found when we introduced parity in the first place. The success of labor induction in nulliparous was 50.77 and 83.33% in multiparous (P=0.0001). CONCLUSIONS: Cervical length, Bishop score, and parity predict the success of labor induction.

Measure of hemodynamic patterns by thoracic electrical bioimpedance in normal pregnancy and in preeclampsia.

OBJECTIVE: To compare the differences in the hemodynamics between normal pregnancy and preeclampsia, using thoracic electrical bioimpedance. STUDY DESIGN: We compared heart rate, end-diastolic volume, systolic volume, cardiac output, ejection fraction and peripheral vascular resistances in 18 healthy pregnant women with 15 with preeclamptic women at the following intervals: third trimester, 48 h post-partum, 2 and 6 months post-partum. We took the measurements by thoracic electrical bioimpedance. Statistical analysis was performed by means of Wilcoxon rank-sum test and p < 0.05 was considered statistically significant. RESULTS: The heart rate was lower in the preeclampsia group during the third trimester and the systolic volume was also lower at 48 h post-partum; this implies a lower cardiac output in women with preeclampsia during pregnancy and in the immediate puerperium. The systemic vascular resistances were higher in preeclampsia in the third trimester and at 48 h post-partum. At 2 and 6 months post-partum, the hemodynamic situation had equalized in both groups. CONCLUSIONS: Preeclampsia is a situation of low cardiac output and high peripheral resistances compared with a normal pregnancy.