How ultrafine particles and micro‑nano plastics affect fetal development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational case‑control study of 1,600 newborns comparing preterm and full‑term births, with a 1:2 control ratio in participating countries. A nested personal exposure monitoring substudy will equip 150 pregnant mothers (50 per location) with sensors to measure individual ultrafine particle and micro‑plastic exposure and collect biological samples including urine. Participants are non‑smoking women aged 18 or older who have lived in the study area at least one year and enroll early in pregnancy; exclusions include multiple pregnancy, known kidney disease, significant pregnancy complications, or late first visit. Data will be used to link measured exposures in pregnancy to timing of delivery and early‑life markers that may predispose to later non‑communicable diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Where it's running

• Instituto de Investigación Sanitaria La Fe
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Alba Ruiz Gaitán, Dr
• Email: alba_ruiz@externos.iislafe.es
• Phone: 0034961246690

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prenatal yoga to help with birth experience and body image

  This study tests whether a prenatal yoga program can improve how pregnant women perceive traumatic birth, how they feel about their bodies, and their preferred delivery method.

  Recruiting Saglik Bilimleri Universitesi · Bartın, Bartın · NCT07585916

• Preventing abdominal stretch marks in expectant mothers with Stratamark

  This program will try Stratamark on pregnant women to see if applying it to the abdomen prevents stretch marks during pregnancy and after birth.

  Recruiting Stratpharma AG · Brisbane · NCT07467837

• Oral health knowledge in pregnant women: does a one-time information leaflet help?

  A one-time printed leaflet is tested to see if it improves oral health knowledge in pregnant women attending Hospital La Fe.

  Recruiting University of Valencia · Valencia, Valencia · NCT07413393

• Outpatient induction of labour with a double‑balloon transcervical catheter for low‑risk pregnant women

  This trial will test whether starting cervical ripening at home with a double‑balloon catheter is as safe, acceptable, and time‑efficient as staying in hospital for low‑risk pregnant women due for induction of labour.

  Recruiting at 2 sites Nantes University Hospital · Nantes, Loire Atlantique and 1 other locations · NCT07265518

• Using placental blood markers to detect fetal stress during labor

  This study will test whether levels of placental markers (sFlt-1, PlGF, and their ratio) can help predict which pregnant people (≥32 weeks) may experience fetal distress during labor.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna and 1 other locations · NCT07258329

• Online psychosocial support for pregnant women after a fetal anomaly diagnosis

  This study tests an online psychosocial support program to help pregnant women told their fetus may have an anomaly cope and protect their mental health.

  Recruiting Sakarya University · Sakarya, Türkiye/Sakarya · NCT07084103

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.