NCT04444206: PreBirthCerv

Prevention of Preterm Birth by Screening of the Consistency Index and Length of the Uterine Cervix in Women With a Single Pregnancy

Status unknown NA Last updated 20 October 2020

What this trial tests

NA trial testing Transvaginal ultrasound cervical length screening in Pregnancy, High Risk in 500 participants. Status unknown.

Timeline

25 April 2020

Primary endpoint
30 October 2021

30 December 2022

Quick facts

Lead sponsor	University of Campania Luigi Vanvitelli
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	500
Start date	25 April 2020
Primary completion	30 October 2021
Estimated completion	30 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• Transvaginal ultrasound cervical length screening

Conditions studied

• Pregnancy, High Risk — all drugs for Pregnancy, High Risk →
• Preterm Birth — all drugs for Preterm Birth →
• Cervix; Pregnancy — all drugs for Cervix; Pregnancy →
• Obstetric Labor, Premature — all drugs for Obstetric Labor, Premature →

Sponsor

University of Campania Luigi Vanvitelli

Who can join

Adults 18 to 50, female only, with Pregnancy, High Risk or Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.

Other strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix.

However, the predictive value of the research has recently been questioned, as the threat rate from preterms in the low-risk population has not decreased over time. Numerous clinical studies have been conducted to improve and identify effective prevention strategies in the threat of preterm birth. Among the parameters studied, in addition to the measurement of the uterine cervix and its complaints during the three trimesters of pregnancy, an evaluation of the cervical consistency index (CCI) was also proposed, i.e. an ultrasound evaluation of cervical softness.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.