200 Participants Needed

Cerclage for Short Cervix in Twin Pregnancy

(TWIN-UIC Trial)

Recruiting at 7 trial locations
AR
Overseen ByAmanda Roman, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

Research suggests that cervical cerclage can be effective in preventing preterm birth in twin pregnancies, especially when there is a history of late pregnancy loss or preterm birth, or when the cervix is shortening or dilating.12345

Is cervical cerclage safe for humans?

Cervical cerclage, also known as a cervical stitch, is a surgical procedure that has been used in various pregnancies, including twin pregnancies, to prevent preterm birth. While its effectiveness in multiple pregnancies is debated, the procedure itself is generally considered safe for humans.16789

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

AR

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

Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
I do not have any symptoms.
I am a pregnant woman over 18 years old.
See 1 more

Exclusion Criteria

Transvaginal cervical length >15mm
Major fetal structural anomaly
I have been diagnosed with an infection of the placenta and amniotic fluid.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cervical cerclage and/or daily vaginal progesterone from diagnosis of short cervix to 36 weeks

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks postpartum

Treatment Details

Interventions

  • Cervical cerclage
Trial Overview The study is testing if placing a stitch around the cervix (cervical cerclage) can prevent premature birth in women carrying twins who have a short cervix. It's done at multiple centers where women are randomly chosen to receive this procedure or not.
Participant Groups
2Treatment groups
Active Control
Group I: Cervical cerclage + vaginal progesteroneActive Control1 Intervention
Cervical cerclage in twin pregnancy with transvaginal cervical length ≤15mm and Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
Group II: Vaginal progesteroneActive Control1 Intervention
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks

Cervical cerclage is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Cervical cerclage for:
  • Prevention of preterm birth in women with cervical insufficiency
  • Prevention of preterm birth in women with short cervical length
🇺🇸
Approved in United States as Cervical cerclage for:
  • Prevention of preterm birth in women with cervical insufficiency
  • Prevention of preterm birth in women with short cervical length
🇨🇦
Approved in Canada as Cervical cerclage for:
  • 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

Trials
475
Recruited
189,000+

Federico II University

Collaborator

Trials
403
Recruited
136,000+

Findings from Research

In a study of 69 twin pregnancies with a history of late pregnancy loss or prematurity, preventive cervical cerclage did not significantly reduce the rate of prematurity before 34 weeks of gestation compared to those who did not receive the procedure (45.0% vs. 44.9%).
The study suggests that preventive cervical cerclage may not be an effective intervention for preventing prematurity in this high-risk group, as the outcomes were similar regardless of whether the cerclage was performed.
[Effectiveness of preventive cervical cerclage to prevent preterm birth in women with twin gestation with obstetrical history of late pregnancy loss or preterm birth].Métairie, M., Korb, D., Morin, C., et al.[2019]
In a study of 177 twin pregnancies with cervical shortening, transvaginal cerclage significantly increased the gestational age at delivery (32.1 weeks vs 28.3 weeks) and neonatal survival rate (86.4% vs 47.9%) compared to no cerclage treatment.
For twin pregnancies with cervical lengths less than 10 mm, cerclage showed even greater benefits, with a gestational age of 31.3 weeks and an 85.4% survival rate, while no significant advantages were observed for cervical lengths between 10-15 mm.
Transvaginal cerclage for prevention of preterm birth in twin pregnancies with cervical dilatation or shortening: A prospective observational study.Xu, W., Ni, X., Liu, Y., et al.[2023]
In a study of 42 twin pregnancies undergoing cervical cerclage (CC), the incidence of preterm delivery was notably high, with rates of 32% for ultrasound-indicated CC and 50% for physical examination-indicated CC.
Despite the high risk of preterm delivery, the overall perinatal survival rates were impressive, at 96% for ultrasound-indicated CC and 86% for physical examination-indicated CC, highlighting the need for further research on the efficacy of CC in these cases.
Cervical cerclage in twin pregnancies.Zanardini, C., Pagani, G., Fichera, A., et al.[2016]

References

[Effectiveness of preventive cervical cerclage to prevent preterm birth in women with twin gestation with obstetrical history of late pregnancy loss or preterm birth]. [2019]
Transvaginal cerclage for prevention of preterm birth in twin pregnancies with cervical dilatation or shortening: A prospective observational study. [2023]
Cervical cerclage in twin pregnancies. [2016]
The use of cervical cerclage in asymptomatic twin pregnancies with cervical shortening or dilation: a twelve-year retrospective cohort study. [2023]
Outcomes following rescue cerclage in twin pregnancies. [2018]
Cervical cerclage in twin pregnancies: An updated systematic review and meta-analysis. [2021]
Efficacy of emergency cervical cerclage in twin pregnancies and factors affecting the clinical effects of emergency cerclage. [2023]
Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy. [2023]
[Can by preventive cervix cerclage the premature birth rate in multiple pregnancy be reduced? A retrospective statistical analysis on effectiveness of cerclage using the Bavarian Perinatal Survey 1978-1980]. [2006]
Twin pregnancies treated with emergency or ultrasound-indicated cerclage to prevent preterm births. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Emergency cervical cerclage in twin and singleton pregnancies with 0-mm cervical length or prolapsed membranes. [2021]
[Cervical cerclage in 2008]. [2008]
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