Pregnant WomenUPRISENCT07238608
Impact of UFPs and MNPs on Fetal Health
An observational study of Pregnant Women, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women
- How many people
- 1,600 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant mothers will be recruited at the first antenatal visit (around eight weeks of gestation).
Who may be able to join
- Agreement to sign the informed consent;
- Non-smoking mothers and no exposure to environmental (second-hand) smoke (smoking influences UFP measurements);
- ≥18 years old (mothers have to place sensors, mothers with childhood pregnancies may live at their parental home);
- Not expecting to terminate the pregnancy (no measurements of the child);
- Having resided in the geographical area of research for a minimum period of 1 year (to be eligible for modeling exposures).
Who cannot join
- First visit after 11 weeks of gestation (to ensure 2-week monitoring in the first trimester);
- Pregnancy complications that limit exposure measurements in urine (because it may cause polyuria, for example, gestational diabetes);
- Known kidney disease (might influence exposure measurements in urine);
- Multiple pregnancy (twin or more pregnancies may have a higher risk for complications or preterm birth, no measurements in the last trimester).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Sanitaria La Fe
Valencia, Valencia, 46016
Alba Ruiz Gaitán, Dr, 0034961246690, alba_ruiz@externos.iislafe.es
About this study
Official title: UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health
This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a higher likeliness to suffer non-communicable diseases (NCD) later in the life.
Read the detailed description
The characteristics of this study population are as follows:
- Case-control design The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain.
- Personal Exposure Monitoring PEM Substudy:
The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed.
- Conditions
- Pregnant Women
- Keywords
- non-communicable diseases, Ultrafine Particulate, micro nano plastics
- Medical subject headings
- Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case-control design | The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain. ENVIRONAGE, Belgium, employs a nested case-control design, making use of its prospective cohort framework that is already in place. | |
| Personal Exposure Monitoring PEM Substudy | The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PreTerm Birth
Measured: at the moment of birth
Small for Gestational Age
Measured: at the moment of birth
Low Birth Weigth
Measured: at the moment of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Hasselt University, Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Alba Ruiz Gaitán, Instituto de Investigacion Sanitaria La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238608
- Sponsor's protocol ID
- UPRISE
- Other IDs
- 1011566
- Acronym
- UPRISE
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPRISE Unravelling Ultrafine Particulate Matter and Micro Nano Plastic's Mechanisms of Impact on Fetal Health
- ClinicalTrials.gov ID
- NCT07238608
- Acronym / sponsor ID
- UPRISE / UPRISE
- Conditions
- Pregnant Women
- Keywords
- non-communicable diseases, Ultrafine Particulate, micro nano plastics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Hasselt University, Aristotle University Of Thessaloniki
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims at unravelling mechanisms by which exposure to air pollution (in particular Ultrafine Particulate (UFP, PM0.1), and micro nano plastic's) interferes with the normal foetus development, with a short-term causal effect in higher likeliness of preterm delivery which, in consequence, precondition a higher likeliness to suffer non-communicable diseases (NCD) later in the life.
Detailed description
The characteristics of this study population are as follows:
- Case-control design The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain.
- Personal Exposure Monitoring PEM Substudy:
The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case-control design | – | –The study includes 1600 participants, providing a substantial sample for analysis. The focus is on newborns (age 0), making the study particularly relevant for understanding factors and outcomes related to this very early stage of life. The sex of the participants is expected to be randomly distributed. A control arm of full-term neonates (>37 weeks) will be recruited for a 1:2 ratio in Greece and Spain. ENVIRONAGE, Belgium, employs a nested case-control design, making use of its prospective cohort framework that is already in place. |
| Personal Exposure Monitoring PEM Substudy | – | –The study consists of 150 mothers, with 50 from each location. All participants are females aged over 18 years. The sex of the participants is expected to be randomly distributed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant mothers will be recruited at the first antenatal visit (around eight weeks of gestation).
Key inclusion criteria (5 listed)
- Agreement to sign the informed consent;
- Non-smoking mothers and no exposure to environmental (second-hand) smoke (smoking influences UFP measurements);
- ≥18 years old (mothers have to place sensors, mothers with childhood pregnancies may live at their parental home);
- Not expecting to terminate the pregnancy (no measurements of the child);
- Having resided in the geographical area of research for a minimum period of 1 year (to be eligible for modeling exposures).
Key exclusion criteria (4 listed)
- First visit after 11 weeks of gestation (to ensure 2-week monitoring in the first trimester);
- Pregnancy complications that limit exposure measurements in urine (because it may cause polyuria, for example, gestational diabetes);
- Known kidney disease (might influence exposure measurements in urine);
- Multiple pregnancy (twin or more pregnancies may have a higher risk for complications or preterm birth, no measurements in the last trimester).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PreTerm Birth
Time frame: at the moment of birth
Small for Gestational Age
Time frame: at the moment of birth
Low Birth Weigth
Time frame: at the moment of birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alba Ruiz Gaitán, Dr (0034961246690, alba_ruiz@externos.iislafe.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PreTerm Birth (time frame: at the moment of birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.