Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth

Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size

Study Overview

• Status: Unknown
• Conditions: Preterm Birth
• Intervention / Treatment: Procedure: Cervical cerclage

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80129
    • Recruiting
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnancy (limits the participants to female gender)
• Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
• 18-50 years of age

Exclusion Criteria:

• Multiple gestation
• Prior spontaneous preterm birth 16-36 6/7 weeks
• Ruptured membranes
• Lethal fetal structural anomaly
• Fetal chromosomal abnormality
• Pessary in place (or planned placement)
• Vaginal bleeding
• Suspicion of chorioamnionitis
• Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
• Painful regular uterine contractions
• Placenta previa

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cervical cerclage; Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix	Procedure: Cervical cerclage; Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
NO_INTERVENTION: No intervention; No cerclage Women randomized to not receive cerclage represent the control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spontaneous preterm birth rates <34weeks	Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal death		Between birth and 28 days of age
Spontaneous preterm birth rates <37, <28 and <24 weeks		Less than 24, 28, and 37 weeks gestation
Type of delivery	Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery	Time of delivery
Spontaneous rupture of membranes	Ruptured membranes <34 weeks	Less than 34 weeks gestation
birth weight		Time of delivery
Chorioamnionitis	histologic diagnosis of chorioamnionitis	Time of delivery
necrotizing enterocolitis		Between birth and 28 days of age
intraventricular hemorrhage	intraventricular hemorrhage (grade 3 or higher)	Between birth and 28 days of age
respiratory distress syndrome		Between birth and 28 days of age
bronchopulmonary dysplasia		Between birth and 28 days of age
blood-culture proven sepsis		Between birth and 28 days of age
neonatal mortality	death of a live-born baby within the first 28 days of life	Between birth and 28 days of age
perinatal death	either fetal mortality or neonatal mortality	Until 28 days of age

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: March 6, 2016
• First Submitted That Met QC Criteria: March 17, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 17, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 33/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO