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Could a simple silicone ring prevent premature birth in twins?

NCT ID NCT02328989

Prevention Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether placing a silicone pessary in the vagina could help prevent premature birth in twin pregnancies where the cervix is short. The trial included 324 women with twin pregnancies between 16 and 24 weeks. The pessary was left in place until delivery or removed at 36 weeks. The goal was to see if this simple device could reduce serious complications or death in newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vaginal pessary (a silicone device placed in the vagina to support the cervix)
What this could lead to
If effective, this simple device could reduce the risk of premature birth and related health problems in twin pregnancies.
What could go wrong
This trial is completed but results may not show a clear benefit. The device may cause discomfort or infection, and its effectiveness in twins is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

324 people

The number who actually took part.

Start date

Nov 2014

Finished

Oct 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnancy

Contacts and locations

Locations

  • CHI Poissy

    Poissy, France

  • CHRU Lille

    Lille, Lille, France

  • CHU Angers

    Angers, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Caen

    Caen, France

  • CHU Nantes

    Nantes, France

  • CHU Saint-Etienne

    Saint-Etienne, France

  • CHU Toulouse

    Toulouse, France, 31059, France

  • CHU Tours

    Tours, France

  • GH Pitié Salpétriêre

    Paris, France

  • Hôpital Antoine Béclère

    Paris, France

  • Hôpital Bicêtre

    Paris, France

  • Hôpital Marseille AP-HM

    Marseille, France

  • Hôpital Necker

    Paris, France

  • Hôpital Robert Debré

    Paris, France

  • Hôpital Saint-Joseph

    Marseille, Marseille, France

  • Hôpital Universitaire de Strasbourg

    Strasbourg, France

  • Maternité Port-Royal Cochin

    Paris, France

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