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NCT Number: NCT06036446

LATe Cerclage in High-risk Pregnancies (LATCH)

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.

Recruiting

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Carolinas Medical Center, Charlotte, North Carolina, United States

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About this study

Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth <37 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years old, pregnant, assigned female at birth
  • Singleton pregnancy
  • TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation

Exclusion criteria

  • Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed >14 weeks, or cotwin pregnancy loss diagnosed >14 weeks
  • Cerclage in situ
  • Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
  • PPROM
  • Active vaginal bleeding
  • Suspected intraamniotic infection
  • Major fetal structural abnormality or chromosomal disorder
  • Placenta previa or accreta
  • Other contraindication to cerclage placement
  • Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone

Treatment and study plan

Cervical cerclage

Procedure

Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.

Other names: Cerclage

Vaginal Suppository Progesterone

Drug

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

Other names: Vaginal progesterone

Primary outcomes

  1. Incidence of preterm birth <37 weeks

    Time frame: At delivery

Secondary outcomes

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

    Time frame: At delivery

  2. Gestational age at delivery

    Time frame: At delivery

  3. Time interval from randomization to delivery

    Time frame: At delivery

  4. Incidence of preterm prelabor rupture of membranes (PPROM)

    Time frame: At occurrence up to 36 weeks and 6 days of gestation

  5. Incidence of intraamniotic infection

    Time frame: At the time of delivery at any gestational age

    Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature > 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [white blood cell count > 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [<15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation.

  6. Neonatal outcomes: incidence of low birthweight (<2500g)

    Time frame: At delivery

  7. Neonatal outcomes: incidence of very low birthweight (<1500g)

    Time frame: At delivery

  8. Neonatal outcomes: incidence of admission to neonatal intensive care unit

    Time frame: At delivery

  9. Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality

    Time frame: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Moti Gulersen, MD, MSc

CONTACT

[email protected]

215-955-5000

Vincenzo Berghella, MD

CONTACT

[email protected]

215-955-5000

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial

Acronym: LATCH

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 14, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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