Evaluation Of Pessaries In Twin Pregnancies With A Short... | NCT00502190

Studies
Evaluation Of Pessaries In Twin Pregnancies With A Short Cervix (25 mm) Between 20-28 WG (EPEGE)

NCT00502190

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 10, 2011Estimated

Enrollment

220Actual

Phase

Phase 3

Conditions

Twin Pregnancy

Interventions

Silicon ring positioned in the vagina, around the cervix

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 16, 2007

First Submission Date that Met QC Criteria

Jul 16, 2007

First Posted Date

Jul 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2011

Last Update Posted Date

Nov 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Silicon ring positioned in the vagina, around the cervix	Device: Silicon ring positioned in the vagina, around the cervix
2	Experimental	Silicon ring positioned in the vagina, around the cervix	Device: Silicon ring positioned in the vagina, around the cervix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Silicon ring positioned in the vagina, around the cervix	Device	Silicon ring positioned in the vagina, around the cervix	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	at least 10 days

Secondary Outcomes

Measure	Description	Time Frame
To evaluate and compare the frequency of the childbirth < 34 SA		before 34 weeks
Deliveries (<34WG)	Deliveries (<34WG)	34 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years (legal majority in France)
Inclusion pessary positioning before 28 WG
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

Exclusion Criteria:

Cerclage
- No more cervix
- Chorioamnionitis
- Abnormal CTG
- Placenta praevia
- Abruptio
- 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacky NIZARD, CCA	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital POISSY-ST GERMAIN EN LAYE		Poissy		78300	France