Cerclage for Short Cervix in Twin Pregnancy
(TWIN-UIC Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Cervical cerclage, Cervical stitch, Cervical encircling, Cervical banding for short cervix in twin pregnancy?
Is cervical cerclage safe for humans?
How does the treatment cervical cerclage differ from other treatments for short cervix in twin pregnancies?
Cervical cerclage is unique because it involves a surgical procedure where a stitch is placed around the cervix to prevent it from opening too early, which can help delay preterm birth in twin pregnancies. Unlike other treatments, it directly addresses the physical issue of cervical shortening, although its effectiveness in twin pregnancies is still debated.68101112
What is the purpose of this trial?
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.
Research Team
Amanda Roman, MD
Principal Investigator
Thomas Jefferson University
Eligibility Criteria
This trial is for women over 18 with twin pregnancies, specifically those who have a short cervical length (≤15mm) detected by ultrasound between 16 and nearly 24 weeks of gestation. Participants should not show symptoms. Women with more than two babies, certain twin complications like Twin-twin transfusion syndrome, or any listed conditions that could complicate pregnancy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cervical cerclage and/or daily vaginal progesterone from diagnosis of short cervix to 36 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cervical cerclage
Cervical cerclage is already approved in European Union, United States, Canada for the following indications:
- Prevention of preterm birth in women with cervical insufficiency
- Prevention of preterm birth in women with short cervical length
- Prevention of preterm birth in women with cervical insufficiency
- Prevention of preterm birth in women with short cervical length
- Prevention of preterm birth in women with cervical insufficiency
- Prevention of preterm birth in women with short cervical length
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor
Federico II University
Collaborator