CompletedNot Applicable

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

Spain3,357 participantsStarted 2022-04-21

Plain-language summary

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).

Who can participate

Age range

16 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * maternal age 16 years or older, and * gestational age less than 14 weeks. Exclusion Criteria: * language barrier preventing informed consent, * gestational age at blood sampling above 14 weeks, and * consent withdrawal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

CMV seroprevalence in first trimester of pregnancy

Timeframe: 18-19 months

Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period

Timeframe: 18-19 months

Fetal infection rate at 2nd trimester amniocentesis

Timeframe: 3-24 months

Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection

Timeframe: 3-24 months

Neonatal infection rate (congenital CMV)

Timeframe: 6-27 months

Trial details

NCT IDNCT05699421

SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Screening trials

Who can participate

Age range

16 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

CMV seroprevalence in first trimester of pregnancy

Timeframe: 18-19 months

Prevalence of CMV primary infection in the first trimester of pregnancy or in the periconceptional period

Timeframe: 18-19 months

Fetal infection rate at 2nd trimester amniocentesis

Timeframe: 3-24 months

Rate of fetal compromise by imaging techniques (ultrasound and MRI) after first trimester / periconceptional CMV infection

Timeframe: 3-24 months

Neonatal infection rate (congenital CMV)

Timeframe: 6-27 months