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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cervical cerclage, a procedure that stitches the cervix to prevent early birth, can reduce preterm birth risk in pregnant individuals with a short cervix. Participants will either receive the cerclage or use a daily progesterone vaginal suppository for comparison. The trial seeks pregnant individuals with a single baby and a cervix length of 25mm or less, as measured by ultrasound between weeks 24 and 27 of pregnancy. As an unphased trial, it offers participants the chance to contribute to important research that could improve outcomes for future pregnancies.

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 shows that cervical cerclage is generally safe for preventing early birth. Studies have found that pregnancies with this procedure usually result in good outcomes, with few complications. One study noted that the fewest complications, such as early water breaking, occurred when cerclage was used based on a woman's medical history.

Vaginal progesterone suppositories are also considered safe and often support the uterus during pregnancy. Both treatments help prevent early birth and are well-tolerated, with minimal risks reported in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial for cervical cerclage and vaginal suppository progesterone in preventing premature birth because these approaches could offer new insights into care for expectant mothers at risk. Cervical cerclage involves a surgical stitch to reinforce the cervix, potentially offering more targeted prevention of early labor compared to medication alone. Meanwhile, the use of vaginal progesterone is a non-invasive method that supports pregnancy by maintaining hormonal balance. Exploring these methods helps us understand their effectiveness in combination or as alternatives to current treatments, which include options like oral progesterone or bed rest.

What evidence suggests that this trial's treatments could be effective for reducing preterm birth?

This trial will compare cervical cerclage with vaginal progesterone suppositories. Research has shown that cervical cerclage, a procedure to keep the cervix closed, can help prevent early births in some cases. One study found that performing this procedure early in pregnancy significantly increased the chances of a full-term birth. Another review found that placing the cerclage before 24 weeks can lower the chances of early birth and help the pregnancy last longer. However, for pregnancies with more than one baby, cerclage has not been proven to prevent early births. Overall, for single pregnancies with certain conditions like a short cervix, cerclage has shown promising results. ^{3 4 6 7 8}

Who Is on the Research Team?

Moti Gulersen, MD, MSc

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9262559/

Analysis of the Timing of Cervical Cerclage Treatment in ... After the operation, the full-term birth rate (82.56% (71/86)) in the early group was higher (21.62% (16/74)) than that in the middle group, and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590161325000080

The effect of an exam-indicated cerclage before 24 weeks ... This review shows that exam-indicated cerclage placed before 24 weeks of gestation reduces preterm birth rates, extends pregnancy, but lacks evidence

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25208049/

Cervical stitch (cerclage) for preventing preterm birth in ... For multiple gestations, there is no evidence that cerclage is an effective intervention for preventing preterm births and reducing perinatal deaths or ...

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

Efficacy of late cervical cerclage for preventing preterm birth in ... Our retrospective study demonstrated that the efficacy and risk of prophylactic cervical cerclage performed at 16 + 0 to 19 + 6 weeks of gestation were ...

5. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/17970-cervical-cerclage

Cervical Cerclage: Purpose, Procedure, Risks & Results Cervical cerclage is a way of keeping your cervix closed during pregnancy to prevent premature birth due to incompetent (weakened) cervix.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35653798/

Cervical cerclage for prevention of preterm birth In our cohort study, singleton pregnancies with cerclages seem to have satisfactory obstetric outcomes. We found a very low prevalence of ...

7. ajog.org ajog.org/article/S0002-9378(22)00836-5/fulltext

Perioperative complications of a transvaginal cervical ... The fewest complications occurred in history-indicated cerclage, varying from 0.0% of preterm premature rupture of membranes (95% confidence ...

8. en.wikipedia.org en.wikipedia.org/wiki/Cervical_cerclage

Cervical cerclage The success rate for cervical cerclage is approximately 80–90% for elective cerclages, and 40–60% for emergency cerclages. A cerclage is considered successful ...