LATe Cerclage in High-risk Pregnancies (LATCH)
ConditionPremature Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-50 years old, pregnant, assigned female at birth
Singleton pregnancy
TVU CL ≤25mm between 24 0/7 - 26 6/7 weeks of gestation
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cervical cerclage
Procedure/SurgeryTransvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
Vaginal Suppository Progesterone
DrugContinuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Treatment groups
329 Participants
are divided into 2 treatment groupsGroup A: CerclageExperimental treatment 2 interventions
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of preterm birth <37 weeks
Time frame
At deliverySecondary outcomes
1
Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks
Time frame
At delivery2
Gestational age at delivery
Time frame
At delivery3
Time interval from randomization to delivery
Time frame
At delivery4
Incidence of preterm prelabor rupture of membranes (PPROM)
Time frame
At occurrence up to 36 weeks and 6 days of gestationSponsors and contacts
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Source ClinicalTrials.gov