RESUMEN
OBJECTIVE: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery in women with a twin pregnancy and short cervix. STUDY DESIGN: This open-label, multicenter, randomized controlled trial included women with a twin pregnancy between 24(+0) and 31(+6) weeks of gestation who were asymptomatic and had a cervical length of 25 mm or less measured by routine transvaginal ultrasound. Women were randomized to receive (or not) 500 mg of intramuscular 17P, repeated twice weekly until 36 weeks or preterm delivery. The primary outcome was time from randomization to delivery. Analysis was performed according to the intent-to-treat principle. RESULTS: The 17P and control groups did not differ significantly for median [interquartile range] time to delivery: 45 (26-62) and 51 (36-66) days, respectively. However, treatment with 17P was associated with a significant increase in the rate of preterm delivery before 32 weeks. CONCLUSION: Twice-weekly injections of 17P did not prolong pregnancy significantly in asymptomatic women with a twin pregnancy and short cervix.
Asunto(s)
Cuello del Útero/diagnóstico por imagen , Hidroxiprogesteronas/uso terapéutico , Embarazo Gemelar , Nacimiento Prematuro/prevención & control , Progestinas/uso terapéutico , Caproato de 17 alfa-Hidroxiprogesterona , Adulto , Femenino , Humanos , Embarazo , Nacimiento Prematuro/tratamiento farmacológico , Resultado del Tratamiento , UltrasonografíaRESUMEN
OBJECTIVE: The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery. STUDY DESIGN: This open-label, multicenter, randomized controlled trial included women with singleton pregnancies admitted at 24-31 weeks' gestation and cervical length less than 25 mm for preterm labor successfully arrested by tocolytic treatment. Randomization assigned them to receive (or not) 500 mg of intramuscular 17P after tocolysis ended, repeated semiweekly until 36 weeks or preterm delivery. The primary outcome was the time from randomization to delivery. RESULTS: Outcome data were available for 184 of 188 women randomized. The 17P and control groups (similar for most baseline characteristics) did not differ significantly for median [interquartile range] time to delivery (64 [42-79] and 67 [46-83] days, respectively) or rates of delivery before 37, 34, or 32 weeks of gestation or adverse perinatal outcomes. CONCLUSION: Semiweekly injections of 17P did not prolong pregnancy significantly in women with tocolysis-arrested preterm labor.