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Completed

NCT Number: NCT00502190

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

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

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Key information

Conditions

Twin Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hopital POISSY-ST GERMAIN EN LAYE

Poissy, 78300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silicon ring positioned in the vagina, around the cervix

Device

Silicon ring positioned in the vagina, around the cervix

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate and compare the frequency of the childbirth < 34 SA

    Time frame: before 34 weeks

  2. Deliveries (<34WG)

    Time frame: 34 weeks

    Deliveries (<34WG)

  3. Evaluate the rate of side effects of pessaries

    Time frame: during the pessaries

    Evaluate the rate of side effects of pessaries

  4. Neonatal outcome

    Time frame: before 28 weeks

    Neonatal outcome

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EPEGE

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2007
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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