Pessary to Prevent Prematurity in Twins in Case of Short Cervix

NCT ID: NCT02328989

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-10-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pessary

Intervention Type: DEVICE

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.

No pessary

No pessary will be placed in the vagina.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Vayssière, PhD

Role: STUDY_DIRECTOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, France, France

CHRU Lille

Lille, Lille, France

Hôpital Saint-Joseph

Marseille, Marseille, France

CHU Angers

Angers, , France

CHU Bordeaux

Bordeaux, , France

CHU Caen

Caen, , France

Hôpital Marseille AP-HM

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 Tours

Tours, , France

Countries

France

References

Groussolles M, Winer N, Sentilhes L, Biquart F, Massoud M, Vivanti AJ, Bouchghoul H, Rozenberg P, Olivier P, Desbriere R, Chauleur C, Perrotin F, Coatleven F, Fuchs F, Bretelle F, Tsatsaris V, Salomon LJ, Sananes N, Kayem G, Houflin-Debarge V, Schmitz T, Benoist G, Arnaud C, Ehlinger V, Vayssiere C; Groupe de Recherche en Gynecologie Obstetrique. Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE). Am J Obstet Gynecol. 2022 Aug;227(2):271.e1-271.e13. doi: 10.1016/j.ajog.2022.01.038. Epub 2022 Feb 3.

Reference Type: RESULT

PMID: 35123930 (View on PubMed)

Other Identifiers

13 7048 01

Identifier Type: -

Identifier Source: org_study_id