Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth

Study Overview
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Brief Summary
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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.

Official Title
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Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial

Conditions
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Preterm Birth

Intervention / Treatment
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* Diagnostic Test: cervical length screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cervical length screening<br>cervical length screening | Diagnostic Test: cervical length screening<br>* transvaginal ultrasound cervical length<br>|
| No Intervention: no screening<br>no screening | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth rate | either spontaneous or indicated preterm delivery | Less than 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preterm birth rate | either spontaneous or indicated preterm delivery | ess than 24, 28, 32, 30, and 34 weeks gestation | 
| admission to neonatal intensive care unit |  | time of delivery | 
| neonatal death |  | Between birth and 28 days of age | 
| birth weight | weight of the baby at the time of delivery | 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 | Between birth and 28 days of age | 
| perinatal death | either fetal or neonatal mortality | Between birth and 28 days of age |