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

Federico II University1,334 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,334

Conditions

Preterm Birth

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

preterm birth rate

either spontaneous or indicated preterm delivery

Time frame: Less than 37 weeks

Secondary Outcomes

preterm birth rate

either spontaneous or indicated preterm delivery

Time frame: ess than 24, 28, 32, 30, and 34 weeks gestation

admission to neonatal intensive care unit

Time frame: time of delivery

neonatal death

Time frame: Between birth and 28 days of age

birth weight

weight of the baby at the time of delivery

Time frame: 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

Time frame: Between birth and 28 days of age

perinatal death

either fetal or neonatal mortality

Time frame: Between birth and 28 days of age

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes