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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03591042
• Other study ID #: 31/18
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1334
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Diagnostic Test:
• cervical length screening
transvaginal ultrasound cervical length

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Naples
Italy	Seconda Università di Napoli Luigi Vanvitelli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preterm birth rate	either spontaneous or indicated preterm delivery	Less than 37 weeks
Secondary	preterm birth rate	either spontaneous or indicated preterm delivery	ess than 24, 28, 32, 30, and 34 weeks gestation
Secondary	admission to neonatal intensive care unit		time of delivery
Secondary	neonatal death		Between birth and 28 days of age
Secondary	birth weight	weight of the baby at the time of delivery	time of delivery
Secondary	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
Secondary	perinatal death	either fetal or neonatal mortality	Between birth and 28 days of age