LATe Cerclage in High-risk Pregnancies (LATCH)

Thomas Jefferson University

Status: Enrolling

Conditions: Premature Birth

Treatments: Drug: Vaginal Suppository Progesterone; Procedure: Cervical cerclage

Study type: Interventional

Funder types: Other

Identifiers

NCT06036446

iRISID-2023-2321

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 329 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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329 participants in 2 patient groups

Cerclage

Experimental group

Description:

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

Treatment:

Drug: Vaginal Suppository Progesterone

Procedure: Cervical cerclage

Control

Other group

Description:

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

Treatment:

Drug: Vaginal Suppository Progesterone