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

NCT ID: NCT04444206

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-25
• Study Completion Date: 2022-12-30

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.

Conditions

Pregnancy, High Risk; Preterm Birth; Cervix; Pregnancy; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CL and CCI 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.

Group Type: EXPERIMENTAL

Transvaginal ultrasound cervical length screening

Intervention Type: PROCEDURE

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.

No CL and CCI screening

The investigators collect data of these pregnant women without any additional ultrasound examination

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Prof. Pasquale De Franciscis

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabiana Savoia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Maddalena Morlando, MD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Locations

University of Campania "Luigi Vanvitelli"

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pasquale De Franciscis, Prof

Role: CONTACT

pasquale.defranciscis@unicampania.it

0039 0815665606

Antonio Schiattarella, MD

Role: CONTACT

aschiattarella@gmail.com

Facility Contacts

Pasquale De Franciscis, Prof

Role: primary

pasquale.defranciscis@unicampania.it

0039 0815665606

Antonio Schiattarella, MD

Role: backup

aschiattarella@gmail.com

Other Identifiers

8451

Identifier Type: -

Identifier Source: org_study_id