Cervical Cerclage for Preventing Premature Birth

(COLORS Trial)

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

93 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Cervical Cerclage and Vaginal Progesterone for preventing premature birth?

Research shows that using both cervical cerclage (a stitch to support the cervix) and vaginal progesterone (a hormone treatment) together can significantly reduce the risk of very early preterm birth compared to using progesterone alone. This combination treatment has been found to prolong pregnancy and increase birth weight in women with cervical shortening. ^{1 2 3 4 5}

Is cervical cerclage safe for preventing preterm birth?

Cervical cerclage and vaginal progesterone are generally considered safe interventions for reducing preterm birth, although the studies focus more on their effectiveness rather than detailed safety data. ^{1 2 3 6 7}

How does the treatment of cervical cerclage and vaginal progesterone differ from other treatments for preventing preterm birth?

The combination of cervical cerclage (a stitch placed in the cervix to prevent it from opening early) and vaginal progesterone (a hormone treatment) is unique because it combines two effective methods to potentially enhance the prevention of preterm birth, although it's unclear if this combination is more effective than using either method alone. ^{1 2 3 8 9}

What is the purpose of this trial?

This trial is studying if stitching the cervix closed can prevent early births in pregnant women with a short cervix who haven't had a previous preterm birth. The procedure aims to provide support to the cervix and reduce the risk of early delivery.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Combined vaginal progesterone and cervical cerclage in the prevention of preterm birth: a systematic review and meta-analysis. [2023]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Combined therapy with vaginal progesterone, Arabin cervical pessary and cervical cerclage to prevent preterm delivery in high-risk women. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Unraveling the Efficacy of Therapeutic Interventions for Short Cervix: Insights from a Retrospective Study for Improved Clinical Management. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Rescue Adjuvant Vaginal Progesterone May Improve Outcomes in Cervical Cerclage Failure. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of combined vaginal progesterone and cervical cerclage in preventing preterm birth: a systematic review and meta-analysis protocol. [2021]

7. China pubmed.ncbi.nlm.nih.gov

Role of Cervical Cerclage and Vaginal Progesterone in the Treatment of Cervical Incompetence with/without Preterm Birth History. [2022]

8. United States 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. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Comparison the efficacy of vaginal progesterone versus 17-alpha-hydroxyprogesterone caproate to prevent preterm birth in high-risk pregnant women undergo cerclage: a randomized clinical trial. [2022]