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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02678026
• Other study ID #: 111/888
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2016
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Device:
• Cervical pessary
Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed.

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

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