Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
Primary Purpose
Preterm Birth
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
cervical length screening
Sponsored by
About this trial
This is an interventional prevention trial for Preterm Birth
Eligibility Criteria
Inclusion criteria are:
- Singleton gestations
- No prior SPTB
Exclusion criteria are:
- Multiple gestations
- History of SPTB in a prior pregnancy
- Rupture of membranes at the time of randomization
- Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
- Fetal death at the time of randomization
- Cerclage in situ at the time of randomization
- Pessary in situ at the time of randomization
- Vaginal bleeding at the time of randomization
- Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
Sites / Locations
- Gabriele SacconeRecruiting
- Seconda Università di Napoli Luigi VanvitelliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
cervical length screening
no screening
Arm Description
cervical length screening
no screening
Outcomes
Primary Outcome Measures
preterm birth rate
either spontaneous or indicated preterm delivery
Secondary Outcome Measures
preterm birth rate
either spontaneous or indicated preterm delivery
admission to neonatal intensive care unit
neonatal death
birth weight
weight of the baby at the time of delivery
Composite of adverse perinatal outcomes
Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death
perinatal death
either fetal or neonatal mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03591042
Brief Title
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
Official Title
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1334 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cervical length screening
Arm Type
Experimental
Arm Description
cervical length screening
Arm Title
no screening
Arm Type
No Intervention
Arm Description
no screening
Intervention Type
Diagnostic Test
Intervention Name(s)
cervical length screening
Intervention Description
transvaginal ultrasound cervical length
Primary Outcome Measure Information:
Title
preterm birth rate
Description
either spontaneous or indicated preterm delivery
Time Frame
Less than 37 weeks
Secondary Outcome Measure Information:
Title
preterm birth rate
Description
either spontaneous or indicated preterm delivery
Time Frame
ess than 24, 28, 32, 30, and 34 weeks gestation
Title
admission to neonatal intensive care unit
Time Frame
time of delivery
Title
neonatal death
Time Frame
Between birth and 28 days of age
Title
birth weight
Description
weight of the baby at the time of delivery
Time Frame
time of delivery
Title
Composite of adverse perinatal outcomes
Description
Number of neonates who will have at least one of the following: necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death
Time Frame
Between birth and 28 days of age
Title
perinatal death
Description
either fetal or neonatal mortality
Time Frame
Between birth and 28 days of age
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria are:
Singleton gestations
No prior SPTB
Exclusion criteria are:
Multiple gestations
History of SPTB in a prior pregnancy
Rupture of membranes at the time of randomization
Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
Fetal death at the time of randomization
Cerclage in situ at the time of randomization
Pessary in situ at the time of randomization
Vaginal bleeding at the time of randomization
Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.
Facility Information:
Facility Name
Gabriele Saccone
City
Naples
ZIP/Postal Code
80100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Saccone
Phone
0817461111
Email
gabriele.saccone.1990@gmail.com
Facility Name
Seconda Università di Napoli Luigi Vanvitelli
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maddalena Morlando
Phone
0817461111
Email
madmorlando@gmail.com
First Name & Middle Initial & Last Name & Degree
Maddalena Morlando, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
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