LATe Cerclage in High-risk Pregnancies (LATCH)

Not Applicable

Recruiting

• Conditions: Premature Birth
• Interventions: Procedure: Cervical cerclage; Drug: Vaginal Suppository Progesterone

• Registration Number: NCT06036446
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-14
• Study Start: 2023-11-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2028-10
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 329

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerclage	Cervical cerclage	Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
Cerclage	Vaginal Suppository Progesterone	Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated.
Control	Vaginal Suppository Progesterone	Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Primary Outcome Measures

Name	Time	Method
Incidence of preterm birth <37 weeks	At delivery

Secondary Outcome Measures

Name	Time	Method
Neonatal outcomes: incidence of very low birthweight (<1500g)	At delivery
Neonatal outcomes: incidence of admission to neonatal intensive care unit	At delivery
Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks	At delivery
Gestational age at delivery	At delivery
Time interval from randomization to delivery	At delivery
Incidence of preterm prelabor rupture of membranes (PPROM)	At occurrence up to 36 weeks and 6 days of gestation
Incidence of intraamniotic infection	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.
Neonatal outcomes: incidence of low birthweight (<2500g)	At delivery
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	At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States