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

Not Applicable

• Conditions: Preterm Birth
• Interventions: Diagnostic Test: cervical length screening

• Registration Number: NCT03591042
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-18
• Study Start: 2018-07-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-03
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1334

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cervical length screening	cervical length screening	cervical length screening

Primary Outcome Measures

Name	Time	Method
preterm birth rate	Less than 37 weeks	either spontaneous or indicated preterm delivery

Secondary Outcome Measures

Name	Time	Method
preterm birth rate	ess than 24, 28, 32, 30, and 34 weeks gestation	either spontaneous or indicated preterm delivery
admission to neonatal intensive care unit	time of delivery
neonatal death	Between birth and 28 days of age
birth weight	time of delivery	weight of the baby at the time of delivery
Composite of adverse perinatal outcomes	Between birth and 28 days of age	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	Between birth and 28 days of age	either fetal or neonatal mortality

Trial Locations

Locations (2)

Gabriele Saccone; 🇮🇹 Naples, Italy

Seconda Università di Napoli Luigi Vanvitelli; 🇮🇹 Napoli, Italy