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

Primary Purpose

Preterm Birth

Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Cervical pessary
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Naples Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cervical Pessary

No intervention

Arm Description

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

No treatment

Outcomes

Primary Outcome Measures

Preterm delivery

Secondary Outcome Measures

Gestational age at delivery
Birth weight
Spontaneous preterm birth rates
Spontaneous rupture of membranes
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
Neonatal death
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
Admission to neonatal intensive care unit
Chorioamnionitis
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
Intolerance to pessary
Defined as request for removal secondary to discomfort and/or discharge
Preterm delivery

Full Information

First Posted
February 4, 2016
Last Updated
August 21, 2021
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02678026
Brief Title
Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Official Title
Pessary as Adjunctive Therapy to Cerclage for the Prevention of Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no enrollment
Study Start Date
January 1, 2016 (undefined)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical Pessary
Arm Type
Experimental
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Device
Intervention Name(s)
Cervical pessary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preterm delivery
Time Frame
Less than 34 weeks gestation
Secondary Outcome Measure Information:
Title
Gestational age at delivery
Time Frame
Time of delivery
Title
Birth weight
Time Frame
Time of delivery
Title
Spontaneous preterm birth rates
Time Frame
Less than 24, 28, 34 and 37 weeks gestation
Title
Spontaneous rupture of membranes
Time Frame
Less than 34 weeks gestation
Title
Type of delivery: rate of cesaran delivery, vaginal delivery and operative vaginal delivery
Time Frame
Time of delivery
Title
Neonatal death
Time Frame
Between birth and 28 days of age
Title
Composite adverse neonatal outcome
Description
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Time Frame
Between birth and 28 days of age
Title
Admission to neonatal intensive care unit
Time Frame
Between birth and 28 days of age
Title
Chorioamnionitis
Time Frame
Time of delivery
Title
significant adverse maternal effects
Description
Includes heavy bleeding, injury (eg erosion; fistula; etc) to vagina; injury (eg erosion; fistula; etc) to bladder, cervical tear and uterine rupture
Time Frame
Time of delivery
Title
Intolerance to pessary
Description
Defined as request for removal secondary to discomfort and/or discharge
Time Frame
prior to delivery
Title
Preterm delivery
Time Frame
Less than 24, 28 and 37 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32970845
Citation
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.
Results Reference
derived

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

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