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

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ClinicalTrials.gov Identifier: NCT02678026
Recruitment Status : Unknown
Verified February 2016 by Gabriele Saccone, Federico II University.
Recruitment status was:  Recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, 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


Condition or disease Intervention/treatment Phase
Preterm Birth Device: Cervical pessary Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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



Primary Outcome Measures :
  1. Preterm delivery [ Time Frame: Less than 34 weeks gestation ]

Secondary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: Time of delivery ]
  2. Birth weight [ Time Frame: Time of delivery ]
  3. Spontaneous preterm birth rates [ Time Frame: Less than 24, 28, 34 and 37 weeks gestation ]
  4. Spontaneous rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
  5. Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery [ Time Frame: Time of delivery ]
  6. Neonatal death [ Time Frame: Between birth and 28 days of age ]
  7. Composite adverse neonatal outcome [ Time Frame: 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 [ Time Frame: Between birth and 28 days of age ]
  9. Chorioamnionitis [ Time Frame: Time of delivery ]
  10. significant adverse maternal effects [ Time Frame: 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 [ Time Frame: prior to delivery ]
    Defined as request for removal secondary to discomfort and/or discharge

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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678026


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80100
Contact: Gabriele Saccone, MD    00393394685179    gabriele.saccone.1990@gmail.com   
Sponsors and Collaborators
Federico II University

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Responsible Party: Gabriele Saccone, Medical Doctor, Federico II University
ClinicalTrials.gov Identifier: NCT02678026     History of Changes
Other Study ID Numbers: 111/888
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications