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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04444206
Other study ID # 8451
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2020
Est. completion date December 30, 2022

Study information

Verified date October 2020
Source University of Campania "Luigi Vanvitelli"
Contact Pasquale De Franciscis, Prof
Phone 0039 0815665606
Email pasquale.defranciscis@unicampania.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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 changes during the three trimesters of pregnancy, the evaluation of the cervical consistency index (CCI), or an ultrasound evaluation of cervical softness, was also proposed. Reduced CCI values correspond to greater compressibility and cervical softness. Studies conducted to study cervical remodeling on animal models suggest an early increase in cervical softness that begins immediately after conception followed by shortening and dilation in the terminal stages of pregnancy so that minimal changes in cervicometry correspond to a significant increase in cervical softness . Therefore the study of the early stages of cervical remodeling, such as cervical softness through the ICC, could allow to identify in a timely manner women with an increased risk of preterm birth. The purpose of this study is to define and standardize the transvaginal technique to determine the CCI, its reference range and establish its potential predictive use in the threat of preterm birth before 32, 34 and 37 weeks. The purpose of this study is to verify the hypothesis that the introduction of a universal screening program with TVU CL and CCI measurement, in the three trimesters of pregnancy, may be associated with a predictive ability to deliver preterm higher than current protocols.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 30, 2022
Est. primary completion date October 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: Singleton gestations 18-50 years of age Exclusion Criteria: Multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Labor or cerclage in situ at the time of randomization Women with altered state of consciousness, seriously ill, with mental handicaps;

Study Design


Intervention

Procedure:
Transvaginal ultrasound cervical length screening
Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.

Locations

Country Name City State
Italy University of Campania "Luigi Vanvitelli" Naples

Sponsors (1)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preterm delivery Less than 37 weeks gestation
Secondary Gestational age at delivery Time of delivery
Secondary Preterm birth rates Less than 24, 28, 34 weeks gestation
Secondary Birth weight Time of delivery
Secondary Low birth weight Birth weight <2500g Time of delivery
Secondary Neonatal death Between birth and 28 days of age
Secondary Composite adverse neonatal outcome Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death Between birth and 28 days of age
Secondary Admission to neonatal intensive care unit Between birth and 28 days of age
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