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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Twin Pregnancy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00502190

P050322

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

1

Experimental group

Description:

Silicon ring positioned in the vagina, around the cervix

Treatment:

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

2

Experimental group

Description:

Silicon ring positioned in the vagina, around the cervix

Treatment:

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