Cervical Cerclage for Preventing Premature Birth

(COLORS Trial)

No longer recruiting at 2 trial locations

Overseen By Vincenzo Berghella, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Disqualifiers: Multiple pregnancy, Preterm labor, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18-19 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of cervical cerclage, a surgical stitch to support the cervix, in preventing early births in pregnancies with a single baby when the cervix is shorter than usual. Researchers are comparing two groups: one receiving both the cerclage and a hormone treatment called vaginal progesterone, and another receiving only the hormone treatment. Women who are at least 18, expecting one baby, and have been informed of a short cervix without a history of early birth may be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

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 is the safety track record for cervical cerclage and vaginal progesterone?

Research shows that cervical cerclage, a procedure involving a stitch in the cervix to prevent early opening, has varying safety levels. One study found that women with a certain type of cerclage experienced fewer early preterm births compared to those without it. However, another study identified a higher risk of preterm birth and complications if the woman had undergone specific cervical surgery previously.

For vaginal progesterone, a hormone treatment, studies have shown it is generally well-tolerated and often used to reduce early birth risk in women with a short cervix. Serious side effects are rare, making it a common choice in these cases.

Both treatments are used in medical settings, with well-known risks. Consulting a healthcare provider can help clarify the benefits and risks for each specific situation. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about cervical cerclage combined with vaginal progesterone for preventing premature birth because this approach offers a unique dual-action strategy. Cervical cerclage provides mechanical support to the cervix, potentially reducing the risk of early dilation, while progesterone helps maintain pregnancy by supporting the uterine lining and reducing contractions. Unlike the standard of care, which often involves progesterone alone, this combination aims to address both the mechanical and hormonal aspects of preventing premature birth, potentially improving outcomes for at-risk pregnancies.

What evidence suggests that this trial's treatments could be effective for preventing premature birth?

Research shows that cervical cerclage, a procedure involving a stitch in the cervix, can reduce the risk of early birth in women at higher risk. Studies have found that this treatment significantly lowers the chances of early delivery and may also decrease the risk of infant deaths. For women with shorter cervixes, cerclage can extend pregnancy by a few weeks, which is crucial for the baby's health. In this trial, one group of participants will receive cervical cerclage along with a hormone treatment called vaginal progesterone to further lower the risk of early birth. Another group will receive only vaginal progesterone. Both treatments have strong evidence supporting their effectiveness in managing pregnancies with short cervix conditions. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single baby and a short cervix (less than or equal to 25mm) measured by ultrasound, who haven't had preterm births or losses in the second trimester before. Women can't join if they already have a cerclage, signs of labor, major fetal issues, dilated cervix over 1cm, infection suspicion, multiple babies, ruptured membranes or certain placenta problems.

Inclusion Criteria

Singleton pregnancy

No prior spontaneous preterm birth (SPTB) or second trimester losses between 160 and 366 weeks

Transvaginal ultrasound cervical length (TVU CL) ≤25mm between 180 and 236 weeks

Exclusion Criteria

Multiple pregnancy

Prior spontaneous preterm birth (SPTB) or second trimester losses between 160 and 366 weeks

Rupture membranes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either cervical cerclage or control with vaginal progesterone from randomization until 36 weeks

18-19 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cervical Cerclage
• Vaginal Progesterone

Trial Overview The study tests whether cervical cerclage—a procedure where the cervix is stitched closed—can prevent early birth in low-risk pregnancies with short cervixes compared to using vaginal progesterone which is a hormone treatment aimed at supporting pregnancy.

How Is the Trial Designed?

Group I: Control Experimental Treatment 1 Intervention

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Group II: Cerclage Experimental Treatment 2 Interventions

Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

In women with a history of preterm birth (PTB), cervical cerclage significantly improved maternal and neonatal outcomes compared to vaginal progesterone, leading to longer cervical length, higher rates of delivery at or beyond 37 weeks, and better neonatal health indicators.

For women without a history of PTB, both cervical cerclage and vaginal progesterone showed similar effectiveness in terms of gestational age at delivery and neonatal outcomes, indicating that the treatment choice may depend on the patient's history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Cervical Cerclage and Vaginal Progesterone in the Treatment of Cervical Incompetence with/without Preterm Birth History. Wang, SW., Ma, LL., Huang, S., et al.[2022]

A systematic review and meta-analysis of 10 trials involving 769 women found that both vaginal progesterone and cerclage are equally effective in preventing preterm birth and improving perinatal outcomes in women with a singleton pregnancy and a short cervix.

Vaginal progesterone significantly reduced the risk of preterm birth and adverse outcomes compared to placebo, while cerclage also showed significant benefits compared to no treatment, but the adjusted analyses indicated no significant differences between the two interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal progesterone is as effective as cervical cerclage to prevent preterm birth in women with a singleton gestation, previous spontaneous preterm birth, and a short cervix: updated indirect comparison meta-analysis. Conde-Agudelo, A., Romero, R., Da Fonseca, E., et al.[2020]

Both vaginal progesterone and cervical cerclage significantly reduce the risk of preterm birth and adverse perinatal outcomes in women with a short cervix and a history of preterm birth, based on an analysis of 662 patients across multiple studies.

There is no statistically significant difference in efficacy between vaginal progesterone and cervical cerclage for preventing preterm birth, suggesting that the choice of treatment should consider factors like side effects, cost, and personal preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal progesterone vs. cervical cerclage for the prevention of preterm birth in women with a sonographic short cervix, previous preterm birth, and singleton gestation: a systematic review and indirect comparison metaanalysis. Conde-Agudelo, A., Romero, R., Nicolaides, K., et al.[2023]

Combining cervical cerclage and vaginal progesterone significantly reduces the risk of preterm birth at <37 weeks compared to using either treatment alone, with risk ratios of 0.51 and 0.75 respectively, based on an analysis of 11 studies.

The combined therapy also leads to better outcomes such as decreased neonatal mortality, increased birthweight, and longer gestational age, suggesting it may be a more effective intervention for high-risk pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined vaginal progesterone and cervical cerclage in the prevention of preterm birth: a systematic review and meta-analysis. Aubin, AM., McAuliffe, L., Williams, K., et al.[2023]

In a study of 286 pregnant women with a short cervical length, a combination treatment of vaginal progesterone, cervical cerclage, and Arabin cervical pessary (group A) showed a higher prevalence of risk factors like cervical incompetence, yet did not lead to a significantly lower rate of preterm delivery compared to other treatment groups.

The results suggest that this combined treatment approach may be effective in managing pregnancies at high risk for preterm birth, potentially prolonging gestation and improving outcomes, but further research is needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined therapy with vaginal progesterone, Arabin cervical pessary and cervical cerclage to prevent preterm delivery in high-risk women. Shor, S., Zimerman, A., Maymon, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28586127/

Cervical stitch (cerclage) for preventing preterm birth in ... Cervical cerclage reduces the risk of preterm birth in women at high-risk of preterm birth and probably reduces risk of perinatal deaths.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003367

The role of cervical cerclage in preventing preterm birth Retrospective studies indicate no benefit of cerclage with a cervix < 15 mm, but do report pregnancy prolongation with lengths ≤ 10 mm (17 weeks vs. 15 weeks, p ...

3. ajogmfm.org ajogmfm.org/article/S2589-9333(23)00113-1/fulltext

The efficacy of emergency cervical cerclage in singleton ... Overall survival after cervical emergency cerclage was 74%, with a fetal survival of 88% and neonatal survival of 90%. Singleton and twin ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07432-3

Efficacy of late cervical cerclage for preventing preterm birth in ... The incidence rate of 5-minute Apgar scores < 7 in the late cerclage group was significantly lower than that in the early cerclage group (1.8%, ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17905

Cervical cerclage: An evolving evidence base - Story - 2024 Rates of preterm birth before 32 weeks were significantly lower in women who received TAC compared with a low vaginal cerclage (8% vs. 33%). The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38649500/

Analysis of perinatal outcomes for emergency cervical ... The rate of adverse neonatal outcomes was 8.33% in the ECC group and 26.42% in the conservative treatment (CT) group, with a statistically ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29970019/

Cerclage is associated with the increased risk of preterm ... Our study showed that cerclage associated with an increased risk of preterm birth and preterm premature rupture of membranes in women who underwent conization.