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

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

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 Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Diagnostic test: cervical length screening

• Study Type: Interventional
• Enrollment (Anticipated): 1334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Recruiting
    • Gabriele Saccone
  • Napoli, Italy
    • Recruiting
    • Seconda Università di Napoli Luigi Vanvitelli
    • Contact: Maddalena Morlando; Phone Number: 0817461111; Email: madmorlando@gmail.com
    • Principal Investigator: Maddalena Morlando, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical length screening	Diagnostic test: cervical length screening; transvaginal ultrasound cervical length
No Intervention: no screening

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 31/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No