Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2024-02-20

Brief Summary

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The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth

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Detailed Description

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Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth \<35 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 pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerclage

Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Group Type EXPERIMENTAL

Cervical cerclage

Intervention Type PROCEDURE

Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

Vaginal progesterone

Intervention Type DRUG

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

Control

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Group Type OTHER

Vaginal progesterone

Intervention Type DRUG

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

Interventions

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Cervical cerclage

Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

Intervention Type PROCEDURE

Vaginal progesterone

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 year old or older
* Singleton pregnancy
* No prior SPTB or second trimester losses between 160 and 366 weeks
* TVU CL ≤25mm between 180 and 236 weeks

Exclusion Criteria

* Multiple pregnancy
* Prior SPTB or second trimester losses between 160 and 366 weeks
* Cerclage in situ
* Painful regular uterine contraction and/or preterm labor
* Rupture membranes
* Major fetal anomaly or aneuploidy
* Active vaginal bleeding
* Placenta previa and/or accreta
* Cervical dilation \>1.0 cm and/or visible membranes by pelvic exam
* Suspicion of chorioamnionitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes