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PregnancyPESSAR'ONENCT02328989

Pessary to Prevent Prematurity in Twins in Case of Short Cervix

A study testing Pessary in people with Pregnancy, run by University Hospital, Toulouse at 18 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Pregnancy
What is being tested?
Pessary
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
324 participants
Where
18 sitesFrance
Study dates
Nov 2014to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Painful regular contractions
  • Major fetal abnormalities
  • Fetal malformation
  • Active vaginal bleeding, placenta praevia
  • Discordance fetal weight more than 40%
  • Treatment with progesterone
Show all 13Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU Angers

    Angers

  • CHU Bordeaux

    Bordeaux

  • CHU Caen

    Caen

  • CHRU Lille

    Lille, Lille

  • Hôpital Saint-Joseph

    Marseille, Marseille

  • Hôpital Marseille AP-HM

    Marseille

  • CHU Nantes

    Nantes

  • GH Pitié Salpétriêre

    Paris

  • Hôpital Antoine Béclère

    Paris

  • Hôpital Bicêtre

    Paris

  • Hôpital Necker

    Paris

  • Hôpital Robert Debré

    Paris

  • Maternité Port-Royal Cochin

    Paris

  • CHI Poissy

    Poissy

  • CHU Saint-Etienne

    Saint-Etienne

  • Hôpital Universitaire de Strasbourg

    Strasbourg

  • CHU Toulouse

    Toulouse, France, 31059

  • CHU Tours

    Tours

Other trials in France

About this study

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.

Read the 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
Being tested
Pessary
Keywords
prematurity, short cervix, twin pregnancy, pessary
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PessaryDevice

    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.

Study groups in NCT02328989
Study groupRoleWhat they receive
PessaryExperimentalThe 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.
Receives: Device: Pessary
No pessaryNo interventionNo pessary will be placed in the vagina.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (4)

  1. Preterm delivery

    Measured: 6 months

  2. To evaluate the prolongation of pregnancy in days

    Measured: 6 months

  3. The differential cost-efficacy ratio of the two strategies

    Measured: 6 months

  4. Tolerance of the pessary

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328989
Sponsor's protocol ID
13 7048 01
Acronym
PESSAR'ONE
Status last verified
Jul 2020
First submitted
1 Oct 2014
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35123930

Questions about this trial

What is this clinical trial studying?

A study testing Pessary in people with Pregnancy, run by University Hospital, Toulouse at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

perinatal death or significant neonatal morbidity until discharge from the hospital (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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