Preterm BirthPREMAPESSAIRENCT02484820
Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor
A study testing Silicone pessary in people with Preterm Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases. After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Silicone pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2015to 31 Jan 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimal age of 18 years
- Informed consent
- Confirmation of dating of pregnancy by first trimester echography.
- Episode of threatened preterm labour
- Singleton between 24 and 34 weeks of gestation
- Cervical length ≤20mm in cervimetry
- Pulmonary maturation completed
- ≤6 contractions by hour after 24 hours of tocolysis.
Who cannot join
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Spontaneous rupture of membranes at the time of randomization
- Cervical cerclage in situ
- Uterus malformations
- Antecedent of conisation
- Active vaginal bleeding, placenta previa
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- Intra-amniotic infection
- Hydramnios
- Maternal chronic pathology (hypertension, diabetes)
- Anomaly of breathing foetal rate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.
After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.
Read more
A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.
The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.
To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.
- Conditions
- Preterm Birth
- Being tested
- Silicone pessary
- Keywords
- Preterm Birth, pessary, threatened preterm labor
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone pessaryDevice
Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)
| Study group | Role | What they receive |
|---|---|---|
| Pessary | Experimental | Silicone pessary is associated with standard care Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months) Receives: Device: Silicone pessary |
| Control | No intervention | Standard care only, No silicone pessary will be placed in the vagina. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of spontaneous delivery
Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.
Measured: 37 weeks of gestation
Secondary outcomes (10)
Number of spontaneous delivery
Comparison of the number of spontaneous delivery before 34 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.
Measured: 34 weeks of gestation
Number of spontaneous delivery
Comparison of the number of spontaneous delivery before 28 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.
Measured: 28 weeks of gestation
Number of admission for preterm labor
Comparison of the number of admission for preterm labor from date of randomization until the date of the delivery between the 2 groups.
Measured: from date of randomization until the date of the delivery
Number of fetal-neonatal death
Number of fetal-neonatal death at delivery
Measured: at delivery
Number of birth death
Number of birth death at delivery until 6 weeks after the date of term
Measured: From date of delivery until 6 weeks after the date of term
Number of patients with neonatal morbidity
Number of patient with neonatal morbidity at delivery until 6 weeks after the date of term
Measured: From date of delivery until 6 weeks after the date of term
Number of patients with increase of vaginal discharge
Comparison of the number of patients with increase of vaginal discharge from date of randomization until the date of the delivery between the 2 groups of the study.
Measured: from date of randomization until the date of the delivery
Number of patients with spontaneous pessary ejection
Comparison of the number of patients with pessary ejection from date of randomization until the date of the delivery between the 2 groups of the study.
Measured: from date of randomization until the date of the delivery
Number of patients with discomfort
Comparison of the number of patients with discomfort from date of randomization until the date of the delivery between the 2 groups of the study. The discomfort is measure by a standardized questionnaire.
Measured: from date of randomization until the date of the delivery
number of day between resolutive threatened preterm labor and delivery
Comparison of number of day between the two groups of the study
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start1 Dec 2015
- Primary completion8 Oct 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline CHAULEUR, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484820
- Sponsor's protocol ID
- 1508059
- Other IDs
- 2015-A00672-47
- Acronym
- PREMAPESSAIRE
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2015
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial
- ClinicalTrials.gov ID
- NCT02484820
- Acronym / sponsor ID
- PREMAPESSAIRE / 1508059
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, pessary, threatened preterm labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 8 Oct 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.
After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.
A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.
The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.
To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pessary | Experimental | Device: Silicone pessarySilicone pessary is associated with standard care Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months) |
| Control | No intervention | –Standard care only, No silicone pessary will be placed in the vagina. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Minimal age of 18 years
- Informed consent
- Confirmation of dating of pregnancy by first trimester echography.
- Episode of threatened preterm labour
- Singleton between 24 and 34 weeks of gestation
Key exclusion criteria (10 listed)
- Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- Spontaneous rupture of membranes at the time of randomization
- Cervical cerclage in situ
- Uterus malformations
- Antecedent of conisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silicone pessarySilicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months) | Device | Pessary |
Primary outcome
Number of spontaneous delivery
Time frame: 37 weeks of gestation
Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.
10 secondary outcomes
Number of spontaneous delivery
Time frame: 34 weeks of gestation
Number of spontaneous delivery
Time frame: 28 weeks of gestation
Number of admission for preterm labor
Time frame: from date of randomization until the date of the delivery
Number of fetal-neonatal death
Time frame: at delivery
Number of birth death
Time frame: From date of delivery until 6 weeks after the date of term
Number of patients with neonatal morbidity
Time frame: From date of delivery until 6 weeks after the date of term
Number of patients with increase of vaginal discharge
Time frame: from date of randomization until the date of the delivery
Number of patients with spontaneous pessary ejection
Time frame: from date of randomization until the date of the delivery
Number of patients with discomfort
Time frame: from date of randomization until the date of the delivery
number of day between resolutive threatened preterm labor and delivery
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline CHAULEUR, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone pessary in people with Preterm Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site 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 8 inclusion and 10 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of spontaneous delivery (time frame: 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.