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

Twin Pregnancy Clinical Trial

— EPEGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502190
• Other study ID #: P050322
• Status: Completed
• Phase: Phase 3
• First received: July 16, 2007
• Last updated: November 9, 2011
• Start date: June 2007
• Est. completion date: June 2011

Study information

• Verified date: April 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Twin Pregnancy

Intervention

Device:
• Silicon ring positioned in the vagina, around the cervix
Silicon ring positioned in the vagina, around the cervix

Locations

Country	Name	City	State
France	Hopital POISSY-ST GERMAIN EN LAYE	Poissy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To evaluate and compare the frequency of the childbirth < 34 SA		before 34 weeks	Yes
Secondary	Deliveries (<34WG)	Deliveries (<34WG)	34 weeks	Yes
Secondary	Evaluate the rate of side effects of pessaries	Evaluate the rate of side effects of pessaries	during the pessaries	Yes
Secondary	Neonatal outcome	Neonatal outcome	before 28 weeks	Yes