LATe Cerclage in High-risk Pregnancies (LATCH)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Cervical cerclage
* Drug: Vaginal Suppository Progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerclage<br>Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated. | Procedure: Cervical cerclage<br>* Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.<br>* Other names: Cerclage;Drug: Vaginal Suppository Progesterone<br>* Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.<br>* Other names: Vaginal progesterone;|
| Other: Control<br>Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. | Drug: Vaginal Suppository Progesterone<br>* Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.<br>* Other names: Vaginal progesterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of preterm birth <37 weeks |  | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | At the time of delivery at any gestational age | 
| Neonatal outcomes: incidence of low birthweight (<2500g) |  | At delivery | 
| Neonatal outcomes: incidence of very low birthweight (<1500g) |  | At delivery | 
| Neonatal outcomes: incidence of admission to neonatal intensive care unit |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability