ABSTRACT
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.
Subject(s)
Pessaries , Premature Birth/prevention & control , Progesterone/administration & dosage , Progestins/administration & dosage , Adult , Female , Humans , PregnancyABSTRACT
Objetivos: Valorar la precisión de la determinación ecográfíca del sexo fetal entre las 11 y las 14 semanas en una cohorte no seleccionada de gestantes. Métodos: Se realizó un estudio prospectivo transversal en una serie consecutiva de 636 gestaciones entre las 11 y 14 semanas, en gestantes que acudieron para el estudio ecográfco rutinario de primer trimestre. Se examinó la región genital del feto en un plano mediosagi-tal, visualizando el signo sagital y la dirección en la que apunta el tubérculo genital (craneal en los varones, caudal en las mujeres) ambos indicadores del sexo fetal. La confrmación clínica del sexo fetal se obtuvo después del parto por confrmación telefónica, o por el cariotipo en casos con amniocentesis por indicaciones convencionales. Resultados: Se consiguió asignar el sexo fetal correctamente en el 86,3 por ciento de los fetos. La precisión de la asignación ecográfca del sexo fetal fue mayor en varones que en mujeres (el 90,6 por ciento de los varones fueron asignados correctamente vs el 83,1 por ciento de las mujeres, p<0,05), y se incrementó con la edad gestacional desde un 72 por ciento entre las 11 y 11+6 semanas, un 92 por ciento entre las 12 y las 12+6 semanas, hasta un 95 por ciento entre las 13 y las 13+6 semanas. Conclusión: La determinación ecográfíca del sexo fetal tiene una elevada tasa de precisión a partir de las 13 semanas, lo que sugiere que las pruebas invasivas para la exclusión de enfermedades ligadas al X podrían obviarse cuando se identifca un feto varón a esta edad gestacional. Sin embargo, en fetos identifcados como mujeres esta decisión deberá posponerse hasta una edad gestacional más avanzada.
Objective: To assess the accuracy of fetal gender determination by ultrasound at 11-14 weeks of gestation in a large cohort of unselected population. Methods: A prospective cross-sectional study was performed in 636 consecutive pregnancies at 11-14 weeks of gestation, attending for frst trimester ultrasound screening. The genital region was examined in the mid-sagittal plane to detect the sagittal sign and the direction in which the genital tubercle pointed (cranial for males, caudal for females) both as markers of fetal gender. The clinical confrmation of fetal gender was obtained from telephonic interviews after delivery or from karyotype in cases scheduled to amniocentesis for conventional indications. Results: Fetal gender was correctly determined by ultrasound in 86.3 percent of the fetuses. The accuracy of sex assignment was higher in male fetuses than in female fetuses (90.6 percent of the males fetuses vs 83.1 percent of the females were correctly assigned, p<0.05) and increased with gestational age from 72 percent at 11-11+6 week's to 92 percent at 12-12+6 week's, and 95 percent at 13-13+6 week's gestation (p<0.01). Conclusion: Prenatal gender assignment by ultrasound has a high accuracy rate at 13 to 13+6 weeks. These results suggest that invasive testing can probably be performed in fetuses identifed as males at this gestational age. However in fetuses identifed as females, the decision regarding invasive testing should be postponed until a higher gestational age is achieved.
Subject(s)
Humans , Sex Determination Analysis , Ultrasonography, Prenatal/methods , Cross-Sectional Studies , Genitalia, Female/embryology , Genitalia, Female , Genitalia, Male/embryology , Genitalia, Male , Pregnancy Trimester, First , Prospective StudiesABSTRACT
El manejo tradicional del embarazo ectópico intersticial implica laparotomía y resección cornual. Los recientes avances en ultrasonografía y el desarrollo de técnicas sensibles de determinación de beta-hCG han conducido a un diagnóstico cada vez más temprano de estos casos permitiendo el empleo de opciones terapéuticas conservadoras, como el metotrexato sistémico, que se presenta como una opción segura y eficaz. Presentamos un caso de embarazo ectópico intersticial resuelto con éxito con metotrexato
Traditional management of interstitial pregnancy involves laparotomy with cornual resection. Recent advances in transvaginal ultrasonography and sensitive beta-hCG assays have led to earlier diagnosis of these cases. We report a case of interstitial pregnancy successfully treated with parenteral methotrexate. Prompt recognition of interstitial pregnancy allows conservative approachment and systemic methotrexate presents as an effective and safe option
