NCT03591042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 21, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3.4 years

First QC Date

July 5, 2018

Last Update Submit

April 3, 2021

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • preterm birth rate

    either spontaneous or indicated preterm delivery

    Less than 37 weeks

Secondary Outcomes (6)

  • preterm birth rate

    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

    time of delivery

  • Composite of adverse perinatal outcomes

    Between birth and 28 days of age

  • +1 more secondary outcomes

Study Arms (2)

cervical length screening

EXPERIMENTAL

cervical length screening

Diagnostic Test: cervical length screening

no screening

NO INTERVENTION

no screening

Interventions

cervical length screeningDIAGNOSTIC_TEST

transvaginal ultrasound cervical length

cervical length screening

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton gestations
  • No prior SPTB

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gabriele Saccone

Naples, 80100, Italy

RECRUITING

Seconda Università di Napoli Luigi Vanvitelli

Napoli, Italy

RECRUITING

Related Publications (1)

  • Saccone G, Maruotti GM, Morlando M, Visentin S, De Angelis C, Sarno L, Cosmi E, Torcia F, Costanzi F, Gragnano E, Bartolini G, La Verde M, Borelli F, Savoia F, Schiattarella A, De Franciscis P, Locci M, Guida M; Italian Preterm Birth Prevention (IPP) Working Group. Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study. Am J Obstet Gynecol MFM. 2024 May;6(5S):101267. doi: 10.1016/j.ajogmf.2023.101267. Epub 2024 Feb 19.

    PMID: 38642994DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2018

First Posted

July 18, 2018

Study Start

July 21, 2018

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)