Clinical trial NCT06036446: LATe Cerclage in High-risk Pregnancies (LATCH)
Official title: Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Cervical length
Short cervix
Shortened cervix
Prematurity
Preterm birth
Viability
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 329
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of preterm birth <37 weeks
timeFrame: At delivery
Secondary outcomes:
measure: Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
timeFrame: At delivery
measure: Gestational age at delivery
timeFrame: At delivery
measure: Time interval from randomization to delivery
timeFrame: At delivery
measure: Incidence of preterm prelabor rupture of membranes (PPROM)
timeFrame: At occurrence up to 36 weeks and 6 days of gestation
measure: Incidence of intraamniotic infection
timeFrame: At the time of delivery at any gestational age
measure: Neonatal outcomes: incidence of low birthweight (<2500g)
timeFrame: At delivery
measure: Neonatal outcomes: incidence of very low birthweight (<1500g)
timeFrame: At delivery
measure: Neonatal outcomes: incidence of admission to neonatal intensive care unit
timeFrame: At delivery
measure: 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
timeFrame: At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Moti Gulersen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15.