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

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

Study Overview

• Status: Withdrawn
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Cervical pessary

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • University of Naples Federico II

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
No Intervention: No intervention; No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preterm delivery	Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery		Time of delivery
Birth weight		Time of delivery
Neonatal death		Between birth and 28 days of age
Chorioamnionitis		Time of delivery
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
Admission to neonatal intensive care unit		Between birth and 28 days of age
Spontaneous preterm birth rates		Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes		Less than 34 weeks gestation
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery		Time of delivery
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
Intolerance to pessary	Defined as request for removal secondary to discomfort and/or discharge	prior to delivery
Preterm delivery		Less than 24, 28 and 37 weeks

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

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: 111/888