Cerclage for Twins With Short Cervical Length ≤ 15mm

Last updated: April 23, 2020
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

N/A

Clinical Study ID

NCT03340688
17D.326
  • Ages 18-60
  • Female

Study Summary

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pregnant women more than 18 years of age (limits the participants to female gender)

  2. Diamniotic twin pregnancy

  3. Asymptomatic

  4. Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation

Exclusion

Exclusion Criteria:

  1. Singleton or higher order than twins multiple gestation

  2. Transvaginal cervical length >15mm

  3. Cervical dilation with visible amniotic membranes

  4. Amniotic membranes prolapsed into the vagina

  5. Fetal reduction after 14 weeks form higher order

  6. Monoamniotic twins

  7. Twin-twin transfusion syndrome

  8. Ruptured membranes

  9. Major fetal structural anomaly

  10. Fetal chromosomal abnormality

  11. Cerclage already in place for other indication

  12. Active vaginal bleeding

  13. Clinical chorioamnionitis

  14. Placenta previa

  15. Painful regular uterine contractions

  16. Labor

Study Design

Total Participants: 200
Study Start date:
June 22, 2017
Estimated Completion Date:
June 30, 2025

Study Description

Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. The transvaginal cervical length (TVCL) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (PTB). When short TVCL is identified before 24 weeks, the risk of preterm birth is 60%-70% for TVCL ≤25mm and 80%-90% for TVCL ≤15mm. There are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. The investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.

Connect with a study center

  • The Egyptian IVF Center

    Cairo,
    Egypt

    Active - Recruiting

  • Bologna University

    Bologna,
    Italy

    Active - Recruiting

  • University of Brescia

    Brescia,
    Italy

    Active - Recruiting

  • Università degli Studi di Napoli "Federico II"

    Naples,
    Italy

    Active - Recruiting

  • University of Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • George Washington University

    Washington, District of Columbia 20052
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Austin Maternal Fetal Medicine St David's Health Care

    Austin, Texas 78758
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.