Twin PregnancyPhase 3EPEGENCT00502190
Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)
A Phase 3 study testing Silicon ring positioned in the vagina, around the cervix in people with Twin Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Twin Pregnancy
- What is being tested?
- Silicon ring positioned in the vagina, around the cervix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Jun 2011
- Phase
- Phase 3
- 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
- Age > 18 years (legal majority in France)
- Twin pregnancies, mono or dichorionic, diamniotic
- Transvaginal cervical length ( 25mm between 20 et 28 WG
- Intact membranes
- No signs of infection (negative urine culture, CRP <10mg/l , blood white cell count <15000/ml)
- Patient accepting follow-up
- Covered by health insurance for France
Who cannot join
- Cerclage
- No more cervix
- Chorioamnionitis
- Abnormal CTG
- Placenta praevia
- Abruptio
Show all 18Show fewer
- Bleeding
- PROM
- Singleton or multiple >2
- Monochorionic monoamniotic twin pregnancy
- IUGR
- Preeclampsia or other PIH
- TTTS
- Uncontrolled diabetes
- Other maternal of fetal pathology responsible for preterm deliveries
- Patient included in other therapeutic trials
- Patient without legal freedom to consent
- Homeless or no fixed address
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
Read the detailed description
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.
- Conditions
- Twin Pregnancy
- Being tested
- Silicon ring positioned in the vagina, around the cervix
- Keywords
- pessary, extending pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicon ring positioned in the vagina, around the cervixDevice
Silicon ring positioned in the vagina, around the cervix
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Silicon ring positioned in the vagina, around the cervix Receives: Device: Silicon ring positioned in the vagina, around the cervix |
| 2 | Experimental | Silicon ring positioned in the vagina, around the cervix Receives: Device: Silicon ring positioned in the vagina, around the cervix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the profit of 10 days in the pessary group compared to control.
Demonstrate the profit of 10 days in the pessary group compared to control
Measured: at least 10 days
Secondary outcomes (4)
To evaluate and compare the frequency of the childbirth < 34 SA
Measured: before 34 weeks
Deliveries (<34WG)
Deliveries (<34WG)
Measured: 34 weeks
Evaluate the rate of side effects of pessaries
Evaluate the rate of side effects of pessaries
Measured: during the pessaries
Neonatal outcome
Neonatal outcome
Measured: before 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacky NIZARD, CCA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502190
- Sponsor's protocol ID
- P050322
- Acronym
- EPEGE
- Status last verified
- Apr 2007
- First submitted
- 16 Jul 2007
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG
- ClinicalTrials.gov ID
- NCT00502190
- Acronym / sponsor ID
- EPEGE / P050322
- Conditions
- Twin Pregnancy
- Keywords
- pessary, extending pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jul 2007 (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.
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea
Detailed description
Randomized, opened multicentric study evaluating the Effectiveness of Pessary in the patients with a Gemellary pregnancy and a collar runs between 20 and 28 weeks of amenorrhoea To show that the use of pessary makes it possible to lengthen the duration of the pregnancy of at least 10 days in patients with a twin pregnancy and a uterine collar length < = 25 mm measured by echography between 20 and 28 SA compared to the group controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Silicon ring positioned in the vagina, around the cervixSilicon ring positioned in the vagina, around the cervix |
| 2 | Experimental | Device: Silicon ring positioned in the vagina, around the cervixSilicon ring positioned in the vagina, around the cervix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years (legal majority in France)
- Twin pregnancies, mono or dichorionic, diamniotic
- Transvaginal cervical length ( 25mm between 20 et 28 WG
- Intact membranes
- No signs of infection (negative urine culture, CRP <10mg/l , blood white cell count <15000/ml)
Key exclusion criteria (18 listed)
- Cerclage
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 |
|---|---|---|
| Silicon ring positioned in the vagina, around the cervixSilicon ring positioned in the vagina, around the cervix | Device | 1, 2 |
Primary outcome
Demonstrate the profit of 10 days in the pessary group compared to control.
Time frame: at least 10 days
Demonstrate the profit of 10 days in the pessary group compared to control
4 secondary outcomes
To evaluate and compare the frequency of the childbirth < 34 SA
Time frame: before 34 weeks
Deliveries (<34WG)
Time frame: 34 weeks
Evaluate the rate of side effects of pessaries
Time frame: during the pessaries
Neonatal outcome
Time frame: before 28 weeks
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 10 Nov 2011.
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Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
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Not yet recruiting
MoDi Twin Placental Imaging
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
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.
Jacky NIZARD, CCA principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silicon ring positioned in the vagina, around the cervix in people with Twin Pregnancy, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 18 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 10 Nov 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Demonstrate the profit of 10 days in the pessary group compared to control. (time frame: at least 10 days). 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 10 Nov 2011.