Clinical Trial

Mitigation of Health Effects in Pregnant Women by Reducing Exposure to Heat and Air Pollution

Study acronym: ISMED CLIM PW
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Summary
The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in pregnant women. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce sleep difficulties experienced by pregnant women, measured using the Pittsburgh Sleep Quality Index? Researchers will compare measurements between pregnant women carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Pittsburgh Sleep Quality Index questionnaire in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-19.
Trial Details
NCT Number NCT07609433
Lead Sponsor University of Cyprus
Collaborators: Azienda ospedaliera Garibaldi Catania, University of Catania
Conditions Sleep Quality
Enrollment 102 participants
Start Date 2026-05-01
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-05