Pessary to Prevent Prematurity in Twins in Case of Short Cervix
PESSAR'ONE
1 other identifier
interventional
324
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Nov 2014
Longer than P75 for not_applicable pregnancy
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedDecember 5, 2025
July 1, 2020
3.9 years
October 1, 2014
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Preterm delivery
6 months
To evaluate the prolongation of pregnancy in days
6 months
The differential cost-efficacy ratio of the two strategies
6 months
Tolerance of the pessary
6 months
Study Arms (2)
Pessary
EXPERIMENTALThe 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 INTERVENTIONNo pessary will be placed in the vagina.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CHU Toulouse
Toulouse, France, 31059, 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
Related Publications (1)
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.
PMID: 35123930RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christophe Vayssière, PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2014
First Posted
December 31, 2014
Study Start
November 1, 2014
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
December 5, 2025
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share