Pessary to Prevent Prematurity in Twins in Case of Short Cervix

Pregnancy Clinical Trial

— PESSAR'ONE  

Official title:

Pessary to Prevent Prematurity in Twins in Case of Short Cervix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328989
• Other study ID #: 13 7048 01
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: October 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Premature Birth

Intervention

Device:
• Pessary
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.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Bordeaux	Bordeaux
France	CHU Caen	Caen
France	CHRU Lille	Lille
France	Hôpital Marseille AP-HM	Marseille
France	Hôpital Saint-Joseph	Marseille
France	CHU Nantes	Nantes
France	GH Pitié Salpétriêre	Paris
France	Hôpital Antoine Béclère	Paris
France	Hôpital Bicêtre	Paris
France	Hôpital Necker	Paris
France	Hôpital Robert Debré	Paris
France	Maternité Port-Royal Cochin	Paris
France	CHI Poissy	Poissy
France	CHU Saint-Etienne	Saint-Etienne
France	Hôpital Universitaire de Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perinatal death or significant neonatal morbidity until discharge from the hospital	it's a composite outcome : perinatal death (i.e medical interruption of pregnancy, intrauterine fetal death, or death occurring during the first four weeks after birth, before day 29), or significant neonatal morbidity until discharge from the hospital, defined as one or more of the following complications: bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH) grade III or IV, periventricular leucomalacia (PVL), necrotizing enterocolitis (NEC) grade II or higher, culture proven sepsis, retinopathy of prematurity (ROP) requiring treatment.	6 months
Secondary	Preterm delivery		6 months
Secondary	To evaluate the prolongation of pregnancy in days		6 months
Secondary	The differential cost-efficacy ratio of the two strategies		6 months
Secondary	Tolerance of the pessary		6 months