Clinical trial NCT03251729: Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
Official title: Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Birth
Keywords: cerclage, preterm birth, short cervix
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial of cerclage versus no cerclage in singleton pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Preterm birth <35 weeks
timeFrame: At delivery
Secondary outcomes:
measure: Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks
timeFrame: At delivery
measure: Mean gestational age at delivery
timeFrame: At delivery
measure: Histologically proven clinical chorioamnionitis
timeFrame: At delivery
measure: Neonatal outcomes: birth weight
timeFrame: At delivery
measure: Neonatal outcomes: low birth weight (<2500g),
timeFrame: At delivery
measure: Neonatal outcomes: admission to intensive care nursery
timeFrame: At delivery
measure: Neonatal outcomes: length of neonatal hospital admission
timeFrame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: respiratory distress syndrome
timeFrame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: IVH grade 3 or 4
timeFrame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: retinopathy of prematurity
timeFrame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: bronchopulmonary dysplasia
timeFrame: at least 30 days after delivery, up to 6 months after delivery
measure: Neonatal outcomes: neonatal mortality
timeFrame: 28 days after delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Naples
country: Italy
facility: University of Naples Federico II
city: Rome
country: Italy
facility: University Cattolica del S. Cuore
Study officials:
References:
citation: Berghella V, Ciardulli A, Rust OA, To M, Otsuki K, Althuisius S, Nicolaides KH, Roman A, Saccone G. Cerclage for sonographic short cervix in singleton gestations without prior spontaneous preterm birth: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Nov;50(5):569-577. doi: 10.1002/uog.17457. Epub 2017 Oct 5.