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

Sponsor
Federico II University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02678026
Collaborator
(none)
0
1
2
119
0

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Cervical pessary
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Preterm delivery [Less than 34 weeks gestation]

Secondary Outcome Measures

  1. Gestational age at delivery [Time of delivery]

  2. Birth weight [Time of delivery]

  3. Spontaneous preterm birth rates [Less than 24, 28, 34 and 37 weeks gestation]

  4. Spontaneous rupture of membranes [Less than 34 weeks gestation]

  5. Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery [Time of delivery]

  6. Neonatal death [Between birth and 28 days of age]

  7. 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

  8. Admission to neonatal intensive care unit [Between birth and 28 days of age]

  9. Chorioamnionitis [Time of delivery]

  10. 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

  11. Intolerance to pessary [prior to delivery]

    Defined as request for removal secondary to discomfort and/or discharge

  12. Preterm delivery [Less than 24, 28 and 37 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples Federico II Naples Italy 80100

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gabriele Saccone, Medical Doctor, Federico II University
ClinicalTrials.gov Identifier:
NCT02678026
Other Study ID Numbers:
  • 111/888
First Posted:
Feb 9, 2016
Last Update Posted:
Aug 26, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2021