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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Obstetric Labor Complications; Preterm Birth; Obstetric Labor, Premature; Pregnancy, High Risk; Cervix; Pregnancy
• Intervention / Treatment: Procedure: Transvaginal ultrasound cervical length screening

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pasquale De Franciscis, Prof; Phone Number: 0039 0815665606; Email: pasquale.defranciscis@unicampania.it
• Study Contact Backup: Name: Antonio Schiattarella, MD; Email: aschiattarella@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80138
    • Recruiting
    • University of Campania "Luigi Vanvitelli"
    • Contact: Pasquale De Franciscis, Prof; Phone Number: 0039 0815665606; Email: pasquale.defranciscis@unicampania.it
    • Contact: Antonio Schiattarella, MD; Email: aschiattarella@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: No CL and CCI screening; The investigators collect data of these pregnant women without any additional ultrasound examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preterm delivery	Less than 37 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery		Time of delivery
Birth weight		Time of delivery
Neonatal death		Between birth and 28 days of age
Preterm birth rates		Less than 24, 28, 34 weeks gestation
Low birth weight	Birth weight <2500g	Time of delivery
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
Admission to neonatal intensive care unit		Between birth and 28 days of age

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Fabiana Savoia, MD, University of Campania "Luigi Vanvitelli"; Study Chair: Maddalena Morlando, MD, University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2020
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 17, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound
• Additional Relevant MeSH Terms: Premature Birth; Obstetric Labor Complications; Pregnancy Complications; Obstetric Labor, Premature
• Other Study ID Numbers: 8451 (The Newcastle upon Tyne Hospitals NHS FT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No