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

Not Applicable

• Conditions: Pregnancy, High Risk; Preterm Birth; Cervix; Pregnancy; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications
• Interventions: Procedure: Transvaginal ultrasound cervical length screening

• Registration Number: NCT04444206
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-25
• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-17
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-10-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CL and CCI screening	Transvaginal ultrasound cervical length screening	The Cervical lenght (CL) and the Consistence Cervix Index (CCI) will be evaluated by transvaginal ultrasound. CL and CCI measurements will be expected in the first trimester, between 11 and 13 weeks + 6 days, in the second trimester, between 19 and 22 weeks and in the third trimester between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy, in accordance with current national guidelines.

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Less than 37 weeks gestation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy