Cervical cerclage for twins with short cervix

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

This study is testing if a special stitch in the cervix can help pregnant women with twins and a short cervix avoid giving birth too early.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Thomas Jefferson University (Academic / other)
• Locations: 8 sites (Washington, District of Columbia and 7 other locations)
• Trial ID: NCT03340688 on ClinicalTrials.gov

What this trial studies

This multicenter randomized study aims to evaluate whether ultrasound indicated cervical cerclage can reduce the incidence of spontaneous preterm birth before 34 weeks in asymptomatic women with twin pregnancies and a cervical length of 15mm or less. The study targets women diagnosed via transvaginal ultrasound between 16 to 23 weeks of gestation. Given the high risk of preterm delivery in twin pregnancies, the research seeks to determine if this intervention can improve perinatal outcomes. The study is based on previous case reports suggesting significant reductions in preterm birth rates with cerclage in similar cases.

Who should consider this trial

Good fit: Ideal candidates include asymptomatic pregnant women over 18 years of age with diamniotic twin pregnancies and a transvaginal cervical length of 15mm or less.

Not a fit: Patients with singleton or higher order multiple gestations, cervical dilation, or other specified complications will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of preterm birth and improve neonatal outcomes for women with twin pregnancies and short cervical length.

How similar studies have performed: Previous case reports have suggested that cervical cerclage may significantly reduce preterm birth rates in similar populations, indicating potential success for this approach.

Eligibility criteria

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 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

Where this trial is running

Washington, District of Columbia and 7 other locations

• George Washington University — Washington, District of Columbia, United States (Not_yet_recruiting)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
• Austin Maternal Fetal Medicine St David's Health Care — Austin, Texas, United States (Recruiting)
• The Egyptian IVF Center — Cairo, Egypt (Recruiting)
• Bologna University — Bologna, Italy (Recruiting)
• University of Brescia — Brescia, Italy (Recruiting)
• Università degli Studi di Napoli "Federico II" — Naples, Italy (Recruiting)
• University of Barcelona — Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Amanda Roman, MD — Thomas Jefferson University
• Study coordinator: Amanda Roman, MD

Conditions Twin Pregnancy With Antenatal Problem; Preterm Birth; Short Cervix