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

ConditionSleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorUniversity of Cyprus

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant Women (PW) aged 20 to 35 years

being in the 2nd trimester of a singleton pregnancy (15th-27th week of gestation)

Living in Catania (Italy) or Limassol (Cyprus) districts

Clinically healthy

Disqualifiers

Currently smoking

Presence of any smoking residents in the household

Not residing at the household for at least 5 days a week

Planning to move from the current home within the next two months

Trial design

Treatments tested in this trial

  • Heat intervention
  • Heat and air pollution mitigation intervention

Treatment groups

102 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Cyprus

Lead sponsor

Azienda ospedaliera Garibaldi Catania

Collaborator

University of Catania

Collaborator