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

NCT02678026 | Withdrawn Phase 3 DMC

• 1 other identifier: 111/888
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Preterm delivery

  Less than 34 weeks gestation

Secondary Outcomes (12)

• Gestational age at delivery

  Time of delivery

• Birth weight

  Time of delivery

• 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

Study Arms (2)

Cervical Pessary

EXPERIMENTAL

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

No intervention

NO INTERVENTION

No treatment

Interventions

Cervical pessary DEVICE

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.

Cervical Pessary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80100, Italy

Location

Related Publications (1)

• 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.

  PMID: 32970845 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 9, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 26, 2021

Record last verified: 2021-08

Locations

IT (1)