Cerclage for Twins With Short Cervical Length ≤ 15mm

Description

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.

Conditions

Twin Pregnancy With Antenatal Problem, Preterm Birth, Short Cervix

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Study Overview

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Study Details

Study overview

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.

Cervical Cerclage for Preventing Spontaneous Preterm Birth in Twin Pregnancies With Transvaginal Ultrasound Cervical Length ≤ 15mm: a Study Protocol for a Randomized Clinical Trial

Cerclage for Twins With Short Cervical Length ≤ 15mm

Condition
Twin Pregnancy With Antenatal Problem
Intervention / Treatment

-

Contacts and Locations

Washington

George Washington University, Washington, District of Columbia, United States, 20052

Philadelphia

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States, 19107

Austin

Austin Maternal Fetal Medicine St David's Health Care, Austin, Texas, United States, 78758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Amanda Roman, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

2025-06