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Procedure

Cervical Cerclage for Premature Birth (LATCH Trial)

Q: To whom should this medical research be accessible?

Those wishing to partake in this medical experiment must have been born prematurely and be aged between 18 and 50. In total, the clinical trial is looking for 329 participants.

Q: Does this research project have any openings for participation?

According to clinicaltrials.gov, recruitment for this medical trial is currently in progress. It was initially posted on November 10th 2023 and the latest update occurred on November 28th of the same year.

Q: Is this research accommodating geriatric patients?

The requirements to join this medical trial necessitates that applicants are between 18 and 50 years old. There is also a separate study dedicated for those under the age of 18, as well as an additional 82 trials open to elderly patients over 65.

Q: What is the current capacity for enrolment in this investigation?

Affirmative. According to clinicaltrials.gov, this research is currently enrolling participants; the trial was first posted on November 10th 2023 and has been recently updated on November 28th 2023. The study requires a total of 329 volunteers from one medical centre.

N/A

Recruiting

Led By Moti Gulersen, MD, MSc

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-50 years old, pregnant, assigned female at birth

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Awards & highlights

LATCH Trial Summary

This trial will test if a procedure to close the cervix can help stop preterm birth in women with a short cervix. #preterm #birth #cervicalcerclage

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Cervical cerclage may cause discomfort, bleeding or cramping, while progesterone can lead to headaches, nausea, diarrhea or constipation. There's also potential for allergic reactions or local irritation from the suppository.

LATCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

LATCH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at occurrence up to 36 weeks and 6 days of gestation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at occurrence up to 36 weeks and 6 days of gestation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at occurrence up to 36 weeks and 6 days of gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of preterm birth <37 weeks

Secondary outcome measures

Gestational age at delivery

Incidence of intraamniotic infection

Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks

+6 more

LATCH Trial Design

2Treatment groups

Experimental Treatment

Group I: ControlExperimental Treatment1 Intervention

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

Group II: CerclageExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cervical cerclage

2017

Completed Phase 4

~570

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,160 Total Patients Enrolled

10 Trials studying Premature Birth

13,576 Patients Enrolled for Premature Birth

Moti Gulersen, MD, MScPrincipal InvestigatorThomas Jefferson University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom should this medical research be accessible?

"Those wishing to partake in this medical experiment must have been born prematurely and be aged between 18 and 50. In total, the clinical trial is looking for 329 participants."

Answered by AI

Does this research project have any openings for participation?

"According to clinicaltrials.gov, recruitment for this medical trial is currently in progress. It was initially posted on November 10th 2023 and the latest update occurred on November 28th of the same year."

Answered by AI

Is this research accommodating geriatric patients?

"The requirements to join this medical trial necessitates that applicants are between 18 and 50 years old. There is also a separate study dedicated for those under the age of 18, as well as an additional 82 trials open to elderly patients over 65."

Answered by AI

What is the current capacity for enrolment in this investigation?

"Affirmative. According to clinicaltrials.gov, this research is currently enrolling participants; the trial was first posted on November 10th 2023 and has been recently updated on November 28th 2023. The study requires a total of 329 volunteers from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LATe Cerclage in High-risk Pregnancies (LATCH)

2023. "LATe Cerclage in High-risk Pregnancies (LATCH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036446.