Clinical trial NCT02328989: Pessary to Prevent Prematurity in Twins in Case of Short Cervix
Official title: Pessary to Prevent Prematurity in Twins in Case of Short Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: prematurity
short cervix
twin pregnancy
pessary
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Asymptomatic twin pregnancies between 16 and 24+0 weeks CL \< 25th percentile for GA

- \< 35mm between 16 and 24+0d weeks Vaginal swabs for bacteriological analysis \< 72 hours Patient age \> 18 years Written informed consent obtained French first language (speak, read, understand) French social security cover

Exclusion Criteria:

* Painful regular contractions
* Major fetal abnormalities
* Fetal malformation
* Active vaginal bleeding, placenta praevia
* Discordance fetal weight more than 40%
* Treatment with progesterone
* Patient with cerclage
* Ruptured of membrane
* Twin to twin transfusion syndrome
* Uterine malformation
* Chronic maternal disease (diabetes, hypertension, renal insufficiency, Heparin Treatment)
* Conisation history
* patients subject to a judicial safeguard order, participating in another research study including an exclusion period which has not expired at the time of screening will not be included

Primary outcomes:
measure: perinatal death or significant neonatal morbidity until discharge from the hospital
timeFrame: 6 months
Secondary outcomes:
measure: Preterm delivery
timeFrame: 6 months
measure: To evaluate the prolongation of pregnancy in days
timeFrame: 6 months
measure: The differential cost-efficacy ratio of the two strategies
timeFrame: 6 months
measure: Tolerance of the pessary
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: CHU Caen
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: Hôpital Marseille AP-HM
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: GH Pitié Salpétriêre
city: Paris
country: France
facility: Hôpital Antoine Béclère
city: Paris
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Necker
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Maternité Port-Royal Cochin
city: Poissy
country: France
facility: CHI Poissy
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: Hôpital Universitaire de Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU Toulouse
name: Christophe Vayssière, PhD
role: STUDY_DIRECTOR
References: