LATCH: LATe Cerclage in High-risk Pregnancies

Sponsor

Thomas Jefferson University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06036446

Collaborator

(none)

329

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 cervical length (≤25mm) between 24 0/7-26 6/7 weeks.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Procedure: Cervical cerclage Drug: Vaginal Suppository Progesterone	N/A

Detailed Description

Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short transvaginal cervical length (≤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 Design

Study Type:

Interventional

Anticipated Enrollment :

329 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short transvaginal ultrasound cervical length at 24-26 weeks of gestation.Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short transvaginal ultrasound cervical length at 24-26 weeks of gestation.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cerclage

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

Procedure: Cervical cerclage

Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.

Other Names:

Cerclage

Drug: Vaginal Suppository Progesterone

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

Other Names:

Vaginal progesterone

Other: Control

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

Drug: Vaginal Suppository Progesterone

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

Other Names:

Vaginal progesterone

Outcome Measures

Primary Outcome Measures

Incidence of preterm birth <37 weeks [At delivery]

Secondary Outcome Measures

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 [WBC > 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: 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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
Preterm prelabor rupture of membranes (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 PTB prevention, cerclage, or progesterone