LATe Cerclage in High-risk Pregnancies (LATCH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2029-02-28

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.

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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.

Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerclage

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

Group Type EXPERIMENTAL

Cervical cerclage

Intervention Type PROCEDURE

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

Vaginal Suppository Progesterone

Intervention Type DRUG

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

Control

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

Group Type OTHER

Vaginal Suppository Progesterone

Intervention Type DRUG

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

Interventions

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Cervical cerclage

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

Intervention Type PROCEDURE

Vaginal Suppository Progesterone

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

Intervention Type DRUG

Other Intervention Names

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Cerclage Vaginal progesterone

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes