Back to resultsPessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Primary Purpose
Preterm Birth
Status
Completed
Phase
Phase 3
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
- Singleton pregnancy (limits the participants to female gender)
- Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
Exclusion Criteria:
- Multiple gestation
- Prior spontaneous preterm birth 16-36 6/7 weeks
- 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 or CL = 0 mm on transvaginal ultrasound
- Painful regular uterine contractions
- Placenta previa
Sites / Locations
- Gabriele Saccone
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cervical Pessary
No intervention
Arm Description
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
No pessary No pessary will be used. Subjects will receive standard obstetrical management
Outcomes
Primary Outcome Measures
Spontaneous preterm birth (SPTB) <34 weeks
Spontaneous preterm delivery less than 34 weeks of gestation
Secondary Outcome Measures
SPTB <37w
SPTB <32w
SPTB <28w
Gestational age at delivery
Latency
interval from randomization to delivery in days
preterm premature rupture of membranes
Type of delivery
Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery
Maternal side effects
Vaginal discharge, bacterial vaginosis
Birth weight
Neonatal death
perinatal death
either fetal mortality or neonatal death
Composite adverse perinatal outcome
Includes necrotizing enterocolitis, Intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis, and neonatal death
Chorioamnionitis
Adminssion to neonatal intensive care unit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02716909
Brief Title
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Official Title
Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)
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
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.
The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.
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
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cervical Pessary
Arm Type
Experimental
Arm Description
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No pessary No pessary will be used. Subjects will receive standard obstetrical management
Intervention Type
Device
Intervention Name(s)
Cervical pessary
Intervention Description
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Primary Outcome Measure Information:
Title
Spontaneous preterm birth (SPTB) <34 weeks
Description
Spontaneous preterm delivery less than 34 weeks of gestation
Time Frame
Less than 34 weeks gestation
Secondary Outcome Measure Information:
Title
SPTB <37w
Time Frame
Less than 37 weeks gestation
Title
SPTB <32w
Time Frame
Less than 32 weeks gestation
Title
SPTB <28w
Time Frame
Less than 32 weeks gestation
Title
Gestational age at delivery
Time Frame
Time of delivery
Title
Latency
Description
interval from randomization to delivery in days
Time Frame
time of delivery
Title
preterm premature rupture of membranes
Time Frame
Less than 34 weeks gestation
Title
Type of delivery
Description
Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery
Time Frame
time of delivery
Title
Maternal side effects
Description
Vaginal discharge, bacterial vaginosis
Time Frame
Time of delivery
Title
Birth weight
Time Frame
Time of delivery
Title
Neonatal death
Time Frame
Between birth and 28 days of age
Title
perinatal death
Description
either fetal mortality or neonatal death
Time Frame
fetal death after 20 weeks
Title
Composite adverse perinatal 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
Chorioamnionitis
Time Frame
Time of delivery
Title
Adminssion to neonatal intensive care unit
Time Frame
Between birth and 28 days of age
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 pregnancy (limits the participants to female gender)
Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation
Exclusion Criteria:
Multiple gestation
Prior spontaneous preterm birth 16-36 6/7 weeks
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 or CL = 0 mm on transvaginal ultrasound
Painful regular uterine contractions
Placenta previa
Facility Information:
Facility Name
Gabriele Saccone
City
Napoli
ZIP/Postal Code
80129
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29260226
Citation
Saccone G, Maruotti GM, Giudicepietro A, Martinelli P; Italian Preterm Birth Prevention (IPP) Working Group. Effect of Cervical Pessary on Spontaneous Preterm Birth in Women With Singleton Pregnancies and Short Cervical Length: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2317-2324. doi: 10.1001/jama.2017.18956. Erratum In: JAMA. 2018 May 1;319(17 ):1824.
Results Reference
derived
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Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
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