Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth

Phase 3

Withdrawn

• Conditions: Preterm Birth
• Interventions: Device: Cervical pessary

• Registration Number: NCT02678026
• Lead Sponsor: Federico II University

Brief Summary

Cervical cerclage was devised in the 1950's for women with prior early preterm births (PTB) who developed a dilated cervix detected by manual exam in the second trimester. In contemporary practice, there are three possible indications for cerclage. History-indicated cerclage (HIC) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. Ultrasound-indicated cerclage (UIC) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (TVU) cervical length (CL) \< 25mm in a woman with a prior spontaneous PTB. Physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination.

Randomized trials and meta-analysis of these have shown that UIC is associated with significant reduction in PTB and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. In the United States, the national data shows that the rate of cerclage has decreased in the last few years. The indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. With the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage.

The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB as adjuctive therapy in women with UIC

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-26
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 18-50 years of age
• Singleton gestations
• Women with prior preterm birth and with short cervical length (TVU CL <25 mm) who underwent UIC

Exclusion Criteria

• multiple gestation
• Ruptured membranes
• Lethal fetal structural anomaly
• Fetal chromosomal abnormality
• Vaginal bleeding
• Suspicion of chorioamnionitis
• Ballooning of membranes outside the cervix into the vagina
• Painful regular uterine contractions
• Labor
• Placenta previa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical Pessary	Cervical pessary	Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Women will receive pessary soon after UIC

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Less than 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Spontaneous preterm birth rates	Less than 24, 28, 34 and 37 weeks gestation
Chorioamnionitis	Time of delivery
Preterm delivery	Less than 24, 28 and 37 weeks
significant adverse maternal effects	Time of delivery	Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture
Birth weight	Time of delivery
Spontaneous rupture of membranes	Less than 34 weeks gestation
Neonatal death	Between birth and 28 days of age
Intolerance to pessary	prior to delivery	Defined as request for removal secondary to discomfort and/or discharge
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery	Time of delivery
Gestational age at delivery	Time of delivery
Composite adverse neonatal outcome	Between birth and 28 days of age	Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Admission to neonatal intensive care unit	Between birth and 28 days of age

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy