Cerclage for Short Cervix in Twin Pregnancy

(TWIN-UIC Trial)

Recruiting at 7 trial locations

Overseen By Amanda Roman, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Singleton, Monoamniotic, Anomaly, Labor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

200 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{6 8 10 11 12}

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

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.

Exclusion Criteria

Transvaginal cervical length >15mm

Major fetal structural anomaly

I have been diagnosed with an infection of the placenta and amniotic fluid.

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

Group I: Cervical cerclage + vaginal progesterone Active Control 1 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 progesterone Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cerclage in twin pregnancies. Zanardini, C., Pagani, G., Fichera, A., et al.[2016]

Cervical cerclage in asymptomatic twin pregnancies with cervical shortening or dilation significantly prolongs gestational age at delivery and reduces the rates of preterm birth (PTB) before 28, 32, and 34 weeks, as shown in a study of 58 women over a 12-year period.

Cerclage performed before 24 weeks of gestation is particularly beneficial, leading to higher birth weights and longer intervals between presentation and delivery, while no significant differences were found in outcomes for cerclage performed between 24-28 weeks compared to no cerclage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cervical cerclage in asymptomatic twin pregnancies with cervical shortening or dilation: a twelve-year retrospective cohort study. Tan, H.[2023]

In a study of 36 women with twin pregnancies and premature cervical dilatation, those who received a rescue cerclage had significantly better outcomes, giving birth at a later gestational age (28.9 weeks) compared to those managed expectantly (24.2 weeks).

The use of rescue cerclage also reduced the likelihood of delivering before 34 weeks and 28 weeks, indicating that this intervention can effectively prolong pregnancy and improve perinatal outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes following rescue cerclage in twin pregnancies. Abbasi, N., Barrett, J., Melamed, N.[2018]

Cervical cerclage significantly reduces the risk of preterm birth in twin pregnancies with a cervical length of less than 15 mm, showing lower rates of preterm birth at <37 weeks, <34 weeks, and <32 weeks gestation compared to non-cerclage controls.

This systematic review and meta-analysis included 15 studies with a total of 726 patients receiving cervical cerclage, indicating that this intervention can be an effective treatment strategy for preventing preterm birth in high-risk twin pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical cerclage in twin pregnancies: An updated systematic review and meta-analysis. Liu, Y., Chen, M., Cao, T., et al.[2021]

Emergency cervical cerclage in twin pregnancies with cervical dilation of ≥1.0 cm significantly prolongs gestation age and reduces the frequency of spontaneous preterm birth compared to expectant management, based on a study of 99 cases from December 2015 to December 2021.

Independent risk factors for preterm birth after cerclage include elevated pre-operation white blood cell count (WBC > 11.55 × 10^9/L), C-reactive protein (CRP > 10.1), and cervical dilation greater than 3.5 cm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of emergency cervical cerclage in twin pregnancies and factors affecting the clinical effects of emergency cerclage. Liping, Q., Min, L., Chen, C., et al.[2023]

A systematic review of five trials involving 128 women with multiple gestations found no significant evidence that cervical cerclage reduces perinatal deaths or serious neonatal morbidity compared to no cerclage.

The review indicates that cerclage does not effectively prevent preterm births in multiple pregnancies, suggesting that this surgical intervention may not be beneficial for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy. Rafael, TJ., Berghella, V., Alfirevic, Z.[2023]

A study analyzing 3081 multiple births, including 907 cases of prophylactic cerclage, found that using cerclage did not lower the rate of premature births in multiple pregnancies.

The research, conducted at the Amberg gynecology clinic from 1978 to 1980, suggests that liberal use of cerclage may not be an effective strategy for preventing premature births in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Hägele, D., Zahn, B., Berg, D.[2006]

Cervical cerclage in twin pregnancies with a short cervix can prolong pregnancy duration, with a median latency of 77 days and a median delivery at 33 weeks, indicating potential benefits even in high-risk cases.

The procedure was found to be safe, with no serious complications reported, and resulted in a high neonatal survival rate of 91.5%, suggesting it may be a viable option for managing twin gestations at risk of preterm delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twin pregnancies treated with emergency or ultrasound-indicated cerclage to prevent preterm births. Barbosa, M., Bek Helmig, R., Hvidman, L.[2021]

Emergency cervical cerclage is effective in both singleton and twin pregnancies, with a success rate of 58.5% overall, indicating that it can be a viable option even in extreme cases of cervical length at 0 mm and prolapsed membranes.

The study found no significant difference in the success of cervical cerclage between singleton and twin pregnancies, suggesting that twin pregnancies can be managed similarly to singletons in this context, although twins had higher rates of neonatal unit admission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency cervical cerclage in twin and singleton pregnancies with 0-mm cervical length or prolapsed membranes. Freegard, GD., Donadono, V., Impey, LWM.[2021]

Cervical cerclage is a widely used surgical procedure for over 50 years aimed at preventing preterm deliveries, but its effectiveness is debated due to challenges in accurately diagnosing cervical insufficiency.

The review discusses various types of cerclage, including elective, ultrasound-indicated, emergency, and cervico-isthmic cerclage, highlighting their application in both singleton and multiple pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cervical cerclage in 2008]. Fuchs, F., Senat, MV., Gervaise, A., et al.[2008]

References

1. France pubmed.ncbi.nlm.nih.gov

[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]

2. United States pubmed.ncbi.nlm.nih.gov

Transvaginal cerclage for prevention of preterm birth in twin pregnancies with cervical dilatation or shortening: A prospective observational study. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Cervical cerclage in twin pregnancies. [2016]

4. England pubmed.ncbi.nlm.nih.gov

The use of cervical cerclage in asymptomatic twin pregnancies with cervical shortening or dilation: a twelve-year retrospective cohort study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Outcomes following rescue cerclage in twin pregnancies. [2018]

6. Ireland pubmed.ncbi.nlm.nih.gov

Cervical cerclage in twin pregnancies: An updated systematic review and meta-analysis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of emergency cervical cerclage in twin pregnancies and factors affecting the clinical effects of emergency cerclage. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Cervical stitch (cerclage) for preventing preterm birth in multiple pregnancy. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[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]

10. England pubmed.ncbi.nlm.nih.gov

Twin pregnancies treated with emergency or ultrasound-indicated cerclage to prevent preterm births. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Emergency cervical cerclage in twin and singleton pregnancies with 0-mm cervical length or prolapsed membranes. [2021]

12. France pubmed.ncbi.nlm.nih.gov

[Cervical cerclage in 2008]. [2008]