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

NCT04444206 | Unknown DMC

• 1 other identifier: 8451
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

• Preterm delivery

  Less than 37 weeks gestation

Secondary Outcomes (7)

• Gestational age at delivery

  Time of delivery

• Preterm birth rates

  Less than 24, 28, 34 weeks gestation

• Birth weight

  Time of delivery

• Low birth weight

  Time of delivery

• Neonatal death

  Between birth and 28 days of age

Study Arms (2)

CL and CCI screening

EXPERIMENTAL

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

No CL and CCI screening

NO INTERVENTION

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

Interventions

Transvaginal ultrasound cervical length screening 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.

CL and CCI screening

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton gestations 18-50 years of age

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania "Luigi Vanvitelli"

Naples, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Fabiana Savoia, MD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• Maddalena Morlando, MD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Central Study Contacts

Pasquale De Franciscis, Prof

CONTACT

0039 0815665606; pasquale.defranciscis@unicampania.it

Antonio Schiattarella, MD

CONTACT

aschiattarella@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective, non-pharmacological, non-profit interventional study on women with single pregnancy without a history of previous preterm spontaneous birth. Cervical lenght (CL) and Consistence Cervical Index (CCI) will be assessed by transvaginal ultrasound. CL and CCI measurements will be performed 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 routine ultrasound examinations for monitoring of pregnancy, in accordance with current national guidelines.

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: April 25, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2022
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)