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

Thomas Jefferson University93 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premature Birth

Interventions

Cervical cerclagePROCEDURE

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

Vaginal progesteroneDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Naples Federico II

Naples, Italy

University Cattolica del S. Cuore

Rome, Italy

Outcomes

Primary Outcomes

Preterm birth <35 weeks

Incidence of spontaneous preterm birth less than 35 weeks

Time frame: At delivery

Secondary Outcomes

Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks

Time frame: At delivery

Mean gestational age at delivery

Time frame: At delivery

Histologically proven clinical chorioamnionitis

Time frame: At delivery

Neonatal outcomes: birth weight

Time frame: At delivery

Neonatal outcomes: low birth weight (<2500g),

Time frame: At delivery

Neonatal outcomes: admission to intensive care nursery

Time frame: At delivery

Neonatal outcomes: length of neonatal hospital admission

Time frame: at least 30 days after delivery, up to 6 months after delivery

Neonatal outcomes: respiratory distress syndrome

Time frame: at least 30 days after delivery, up to 6 months after delivery

Neonatal outcomes: IVH grade 3 or 4

Time frame: at least 30 days after delivery, up to 6 months after delivery

Neonatal outcomes: retinopathy of prematurity

Time frame: at least 30 days after delivery, up to 6 months after delivery

Data from ClinicalTrials.gov

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