Cervical Cerclage for Premature Birth

(LATCH Trial)

Overseen By Vincenzo Berghella, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Multifetal reduction, Preterm labor, PPROM, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: From 24 0/7 to 36 6/7 weeks of gestation

329 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 for preventing premature birth?

Research shows that both cervical cerclage (a stitch placed in the cervix to prevent it from opening early) and vaginal progesterone (a hormone treatment) are effective in reducing the risk of preterm birth. Studies suggest that using them together may offer additional benefits, although it's not yet clear if this combination is better than using each treatment alone. ^{1 2 3 4 5}

Is cervical cerclage safe for preventing preterm birth?

Cervical cerclage is generally considered safe for preventing preterm birth, especially in women with a history of preterm birth and a short cervix. Studies have shown that vaginal progesterone, often used alongside cerclage, has a well-established safety profile with no additional safety issues identified. ^{2 4 5 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 to support the cervix) and vaginal progesterone (a hormone insert) is unique because it combines mechanical support with hormonal therapy, potentially offering a more comprehensive approach to preventing preterm birth compared to using either treatment alone. ^{1 2 4 5 8}

What is the purpose of this trial?

The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.

Research Team

Moti Gulersen, MD, MSc

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

This trial is for pregnant individuals, aged 18-50, with a single baby and diagnosed with a short cervix (≤25mm) as measured by ultrasound between the 24th and nearly 27th week of pregnancy. Participants must have been assigned female at birth.

Inclusion Criteria

You are pregnant with one fetus.

I am a pregnant woman between 18 and 50 years old.

The thickness of the Transverse Cerebellar Diameter is no more than 25mm between 24 0/7 and 26 6/7 weeks gestation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 24 weeks of gestation

Treatment

Participants with a short TVU cervical length are randomized to either cervical cerclage or control with vaginal progesterone

From 24 0/7 to 36 6/7 weeks of gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of preterm birth and intraamniotic infection

Until delivery

Treatment Details

Interventions

• Cervical cerclage
• Vaginal Suppository Progesterone

Trial Overview The LATCH study is testing if cervical cerclage—a procedure to stitch the cervix closed—can prevent early births in those with a high risk due to a short cervix. It also examines if vaginal progesterone suppositories are effective in this situation.

Participant Groups

Group I: Control Experimental Treatment 1 Intervention

Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Group II: Cerclage Experimental Treatment 2 Interventions

Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.

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+

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]

This study will compare the efficacy of three interventions—cervical cerclage, vaginal progesterone, and cervical pessary—in preventing spontaneous preterm birth in women with a short cervix, involving 510 participants (170 per group) between 14 and 23 weeks of gestation.

The primary goal is to determine if these interventions are equally effective in reducing the rate of premature births before 37 weeks, which is crucial for improving neonatal outcomes and guiding treatment choices based on personal preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of SuPPoRT: a multi-centre randomised controlled trial to compare three treatments: cervical cerclage, cervical pessary and vaginal progesterone, for the prevention of preterm birth in women who develop a short cervix. Hezelgrave, NL., Watson, HA., Ridout, A., et al.[2023]

In a study of 86 asymptomatic singleton pregnancies undergoing cerclage due to short cervical length, the use of postoperative vaginal progesterone significantly reduced the rate of preterm delivery before 34 weeks from 18.4% to 2.2%.

The median gestational age at delivery was longer in the vaginal progesterone group (38.3 weeks) compared to the control group (37.3 weeks), indicating that vaginal progesterone may improve overall pregnancy outcomes after cerclage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of postoperative vaginal progesterone in ultrasound-indicated cerclage to prevent preterm birth. Park, JY., Jung, YM., Kook, SY., et al.[2022]

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]

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]

Identifying women at risk for preterm birth based on cervical length rather than just obstetric history allows for timely interventions, such as cervical cerclage and progesterone supplementation, which improve outcomes.

Daily vaginal progesterone gel significantly reduces the risk of preterm birth in women with a short cervix (10-20 mm) by 45% before 33 weeks and by 50% before 28 weeks, with a well-established safety profile and no additional safety issues compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment options and recommendations to reduce preterm births in women with short cervix. Slager, J., Lynne, S.[2016]

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. England pubmed.ncbi.nlm.nih.gov

Rationale and design of SuPPoRT: a multi-centre randomised controlled trial to compare three treatments: cervical cerclage, cervical pessary and vaginal progesterone, for the prevention of preterm birth in women who develop a short cervix. [2023]

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

The effect of postoperative vaginal progesterone in ultrasound-indicated cerclage to prevent preterm birth. [2022]

4. 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]

5. 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]

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

Treatment options and recommendations to reduce preterm births in women with short cervix. [2016]

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]