Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy (CITEMB Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3357 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-21

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate a universal cCMV screening programme in the first trimester of pregnancy in primary care in Catalonia (Spain).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers of Cytomegalovirus Fetal Infection and Disease

NCT03090841

Cytomegalovirus Congenital

UNKNOWN

Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

NCT01251744

Infections, Cytomegalovirus Cytomegalovirus Infections

COMPLETED NA

Observational Study of the Management of Infants With Congenital CMV

NCT05855889

Congenital Cmv

RECRUITING

Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)

NCT05170269

Congenital Cytomegalovirus Infection

TERMINATED PHASE3

Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

NCT04841408

Mycoplasma Genitalium Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is the pilot study of implementation of the CMV universal screening program in the first trimester of pregnancy Barcelona and its metropolitan area.

General objective The aim of this study is to evaluate a universal CMV screening programme in the first trimester of pregnancy in primary care.

Specific aims of this pilot study:

1. Estimate the percentage of acceptance of CMV screening in the population
2. To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
3. To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
4. To identify and describe the rate of fetal sequelae (due to the primary CMV infection in the first trimester), obtained by imaging techniques (ultrasound and MRI)
5. To identify and describe the rate of neonatal infection (congenital CMV)
6. To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
7. To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
8. To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
9. To identify and describe the rate of TOP following the diagnosis of fetal anomalies
10. To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CITEMB project participants

This is a single cohort, observational prospective multicenter study. The participating centers of the Barcelona Northern Metropolitan Area are primary attention centers - ASSIR Muntanya, ASSIR Esquerra, ASSIR Santa Coloma de Gramenet, ASSIR Badalona-Sant Adrià and hospitals - Vall d'Hebron University Hospital in Barcelona, BCNatal, Hospital Clínic /Hospital Sant Joan de Déu University of Barcelona and Trias i Pujol University Hospital.