RECRUITING

Cerclage for Twins With Short Cervical Length ≤ 15mm

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-06-22
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03340688

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Pregnant women more than 18 years of age (limits the participants to female gender)
  2. 2. Diamniotic twin pregnancy
  3. 3. Asymptomatic
  4. 4. Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
  1. 1. Singleton or higher order than twins multiple gestation
  2. 2. Transvaginal cervical length \>15mm
  3. 3. Cervical dilation with visible amniotic membranes
  4. 4. Amniotic membranes prolapsed into the vagina
  5. 5. Fetal reduction after 14 weeks form higher order
  6. 6. Monoamniotic twins
  7. 7. Twin-twin transfusion syndrome
  8. 8. Ruptured membranes
  9. 9. Major fetal structural anomaly
  10. 10. Fetal chromosomal abnormality
  11. 11. Cerclage already in place for other indication
  12. 12. Active vaginal bleeding
  13. 13. Clinical chorioamnionitis
  14. 14. Placenta previa
  15. 15. Painful regular uterine contractions
  16. 16. Labor

Contacts and Locations

Study Contact

Amanda Roman, MD
CONTACT
215.955.9200
amanda.roman@jefferson.edu

Principal Investigator

Amanda Roman, MD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University

Study Locations (Sites)

George Washington University
Washington, District of Columbia, 20052
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Austin Maternal Fetal Medicine St David's Health Care
Austin, Texas, 78758
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

  • Amanda Roman, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-22
Study Completion Date2025-06

Study Record Updates

Study Start Date2017-06-22
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Twin Pregnancy With Antenatal Problem
  • Preterm Birth
  • Short Cervix