Cerclage for Short Cervix in Twin Pregnancy

(TWIN-UIC Trial)

Not currently recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cervical cerclage (also known as cervical stitch, cervical encircling, or cervical banding) can prevent early birth in women pregnant with twins. It focuses on women without symptoms but with a cervix measuring 15mm or less, which increases the risk of preterm birth. Participants are divided into two groups: one receives cerclage and daily progesterone treatment, while the other takes only daily progesterone. Women pregnant with twins and diagnosed with a very short cervix might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve outcomes for women with similar conditions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cervical cerclage, a procedure for twin pregnancies with a short cervix, might improve outcomes. Some studies found that cerclage can lower the risk of early birth and increase the chances of healthy births. For instance, one study reported very high live birth rates for twins when cerclage was used, with some groups achieving rates as high as 100%.

However, earlier research produced mixed results, with some suggesting it might increase the risk of preterm birth (before 37 weeks). Despite this, more recent studies suggest that cerclage can be helpful for women with twin pregnancies and a short cervix.

Cervical cerclage is already used in other pregnancy situations, indicating a certain level of safety and understanding of its effects. For those considering joining a trial involving cerclage, these findings offer insight into its use and potential safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Cervical cerclage for twin pregnancies with a short cervix is unique because it provides mechanical support to the cervix, potentially preventing premature birth. Unlike standard treatments that rely solely on hormonal support like vaginal progesterone, cerclage physically reinforces the cervix. Researchers are excited because combining cerclage with vaginal progesterone might offer a dual approach—structural and hormonal—potentially improving outcomes for mothers carrying twins, who are at higher risk of preterm birth. This combination approach could bring new hope for better managing this challenging condition.

What evidence suggests that cervical cerclage might be an effective treatment for preventing preterm birth in twin pregnancies with a short cervix?

This trial will compare the effectiveness of cervical cerclage combined with vaginal progesterone to vaginal progesterone alone in twin pregnancies with a short cervix. Research has shown that cervical cerclage can help in such pregnancies. Studies have found that it may lower the risk of early preterm birth and improve newborn health. Specifically, cerclage has been associated with reducing the chances of giving birth before 28, 32, and 34 weeks of pregnancy. This treatment might be especially helpful when the cervix is very short. Overall, evidence suggests that cerclage could improve pregnancy outcomes in these cases. ^{4 6 7 8 9}

Who Is on the Research Team?

Amanda Roman, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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

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

Transvaginal cervical length >15mm

Major fetal structural anomaly

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38184898/

The effectiveness of cervical cerclage in twin pregnancies ... Conclusion: Our data suggest that cerclage in asymptomatic twin pregnancies with a short cervix may reduce the earliest SPB and may improve neonatal outcome.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11550799/

Pregnancy outcomes of twin pregnancies with cervical ... Overall, cervical cerclage appears to improve pregnancy outcomes in twin pregnancies under specific conditions.

3. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004526

Cervical cerclage versus cervical pessary with or without ... Conclusions. In this prematurely halted study on pregnant women with twins and a CL ≤28 mm, cerclage and cervical pessary were comparably effective on PTB <34 ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-06013-6

The use of cervical cerclage in asymptomatic twin ... The use of cervical cerclage appeared to reduce the rates of PTB before 28, 32 and 34 weeks of gestation and adverse perinatal outcomes in ...

5. intechopen.com intechopen.com/chapters/88657

Cervical Length and Perinatal Outcome This study demonstrated that suture ligation in twin pregnancies does not harm but instead provides a benefit when cervical length decreases on consecutive ...

6. utswmed.org utswmed.org/medblog/cerclage-twin-pregnancy-risks/

Cerclage may reduce the risk of premature labor in some ... Emergency cerclage placement may extend pregnancy nearly six weeks and reduce infant mortality by 77%.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10540472/

The use of cervical cerclage in asymptomatic twin ... Some early studies reported that cerclage increased the risk of PTB [19, 20], while some recent studies found that cervical cerclage reduced ...

8. researchgate.net researchgate.net/publication/334236062_Cervical_cerclage_in_twin_pregnancy

Cervical cerclage in twin pregnancy | Request PDF In our research, the live birth rates of twins in women with cerclage were 93.33%, 100% in the ultrasound indication group, and 86.67% in the physical ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02912390

NCT02912390 | Cerclage for Short Cervix in Twins To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation. 1 year. Secondary Outcome ...