Prevention of Preterm Birth With a Pessary in Triplet
Primary Purpose
Preterm Birth
Status
Withdrawn
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Cervical Pessary
Sponsored by

About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- 18-50 years of age
- Triplet pregnancy (limits the participants to female gender)
- Gestational age at randomization between 20(0) and 22(6)
Exclusion Criteria:
- Singleton, twin or higher order than triplets multiple gestation
- Twin twin transfusion syndrome
- Ruptured membranes
- Lethal fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage in place (or planned placement)
- Vaginal bleeding
- Suspicion of chorioamnionitis
- Ballooning of membranes outside the cervix into the vagina
- Painful regular uterine contractions
- Labor
- Placenta previa
Sites / Locations
- Gabriele Saccone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cervical Pessary
Routine care (watch and wait)
Arm 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. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
Outcomes
Primary Outcome Measures
Preterm delivery
Secondary Outcome Measures
Gestational age at delivery
Birth weight
pontaneous 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
NCT ID
NCT02601443
First Posted
November 9, 2015
Last Updated
November 15, 2018
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02601443
Brief Title
Prevention of Preterm Birth With a Pessary in Triplet
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
never started
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (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
The incidence of multiple gestations has increased over the past years, mostly because of increased use of assisted reproductive technologies. Triplet pregnancies are at increased risk of preterm birth (PTB), which is the primary reason for their increased morbidity and mortality compared to singletons. Multiple gestations, including triplets, account for about 3% of all pregnancies in the US but constitute at least 10% of cases of PTB, over 30% of very low birth weight infants, and nearly 20% of infant mortality.
A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of PTB, including in multiple gestations. In singletons with a prior PTB and a short CL <25mm before 24weeks, cerclage is associated with significant decreases in PTB and perinatal morbidity and mortality in the meta-analysis of randomized trials (RCTs). On the contrary, the effect of cerclage in multiple gesttations has been insufficiently studied, with meta-analysis data showing a possible harm from cerclage compared to controls.
The aim of this RCT is to evaluate the efficacy of cervical pessary in prevention of PTB in unselected triplet gestations.
We planned to assess outcomes in subgroup analysis of women with short cervical length (TVU CL <30 mm)
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 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
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). 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 has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
Arm Title
Routine care (watch and wait)
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Cervical Pessary
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
pontaneous 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
Triplet pregnancy (limits the participants to female gender)
Gestational age at randomization between 20(0) and 22(6)
Exclusion Criteria:
Singleton, twin or higher order than triplets multiple gestation
Twin twin transfusion syndrome
Ruptured membranes
Lethal fetal structural anomaly
Fetal chromosomal abnormality
Cerclage in place (or planned placement)
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
Gabriele Saccone
City
Naples
ZIP/Postal Code
80100
Country
Italy
12. IPD Sharing Statement
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Prevention of Preterm Birth With a Pessary in Triplet
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