Pessary to Prevent Prematurity in Twins in Case of Short Cervix
Condition: Pregnancy
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      For 25 years, the twin pregnancy rate has regularly increased in the majority of European
      countries and in the United States, by 35% between 1981 and 2006. Increased use of medically
      assisted procreation and older maternal age are the two main causes. At the present time twin
      pregnancies represent nearly 20% of premature deliveries. The rate of very premature births
      (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As
      prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is
      the principal cause of neonatal mortality and of brain sequelae in twins, the search for a
      preventive treatment appears as a priority in perinatal medicine. The investigators recently
      showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a
      better predictive investigation of premature delivery < 34 wks than digital examination.
      Recently in a randomized trial in a population of short-cervix singleton pregnancies, the
      premature delivery rate decreased by 40% in the pessary group compared with the usual
      management group. No other trial of pessary use in short-cervix twin pregnancies was
      published today. Recently, in a historical comparison of twins with twin-to-twin transfusion
      syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery
      with the use of pessary in case of short cervix. The investigators wish to set up a
      randomized multicenter study in France in the population of short-cervix twin pregnancies to
      show a potential benefit of the pessary compared with simple surveillance.
    

Detailed description: 
      For 25 years, the twin pregnancy rate has regularly increased in the majority of European
      countries and in the United States, by 35% between 1981 and 2006. Increased use of medically
      assisted procreation and older maternal age are the two main causes. At the present time twin
      pregnancies represent nearly 20% of premature deliveries. The rate of very premature births
      (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As
      prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is
      the principal cause of neonatal mortality and of brain sequelae in twins, the search for a
      preventive treatment appears as a priority in perinatal medicine. The investigators recently
      showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a
      better predictive investigation of premature delivery < 34 wks than digital examination.[1]
      As there is currently no recommended preventive treatment for prematurity in twin
      pregnancies[2], the 2009 guidelines of the College of Obstetricians leave the teams with the
      option of carrying out systematic cervical ultrasound or not during follow-up
      investigations.[3] Recently in a randomized trial in a population of short-cervix singleton
      pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with
      the usual management group.[4] In a recent multicenter trial (ProTWIN), while therapeutic
      efficacy of the pessary (versus usual management) was not demonstrated in the overall group
      of twin pregnancies, in the short-cervix subgroup (< 25th percentile of the population) the <
      32 wks delivery rate decreased from 29% to 14% (OR= 0.49 (0.24-0.97) and neonatal morbidity
      also decreased.[5] No other trial of pessary use in short-cervix twin pregnancies was
      published today. Recently, in a historical comparison of twins with twin-to-twin transfusion
      syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery
      with the use of pessary in case of short cervix.[6] The investigators wish to set up a
      randomized multicenter study in France in the population of short-cervix twin pregnancies to
      show a potential benefit of the pessary compared with simple surveillance.
    

Intervention name(s): Pessary
Intervention type(s): Device
Intervention description(s): The device will be placed in the vagina during the consultation. It is rinsed in sterile water for lubrification and left in place until delivery or remove at 36 weeks in case of no delivery before. There is no need to use any analgesia. The good position of the pessary is checking in the same time than the placement with digital examination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prematurity; short cervix; twin pregnancy; pessary