Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies (PESAPRO)

Primary Outcome Measures:

• Proportion of spontaneous preterm birth before 34 weeks of gestation [ Time Frame: up to 11 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  

Secondary Outcome Measures:

• Proportion of spontaneous preterm birth before 37 weeks of gestation [ Time Frame: up to 15 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  
• Proportion of Spontaneous preterm birth before 28 weeks of gestation [ Time Frame: up to 5 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  
• Rate of premature rupture of membranes before 34 weeks of gestation [ Time Frame: up to 11 weeks (from date of ramdomization until delivery) ] [ Designated as safety issue: No ]
  
• Weight at birth [ Time Frame: up to 20 weeks (from date of randomization until delivery) ] [ Designated as safety issue: No ]
  
• Rate of fetal intrauterine mortality during treatment period [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]
  
• Symptomatic vaginal infections during treatment period [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]
  
• Proportion of participants with adverse events [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: Yes ]
  
• Rate of Chorioamnionitis during third term [ Time Frame: From date of randomization until the date of delivery, assesed up 20 weeks ] [ Designated as safety issue: No ]
  

The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. Since 1990, many published articles describe the sonographic measurement of the cervix from the week 16 as method of population screening to detect women at risk. Several studies provide evidence about an inverse relationship between the cervical length and the risk of preterm delivery. For this reason, if there is an effective intervention for patients with cervix short (about < 25mm), made this measure in the middle of the second term, the investigators could reduce the prematurity. Regarding possible therapeutic strategies, recent published data demonstrate the effective of vaginal progesterone and cervical pessary in this population. However, both treatments have never been compared and none of the two strategies are indicated in this population. Therefore it results necessary to compare both treatments in order to establish clinical recommendations. The investigators propose a clinical trial to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries in order to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.