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Evaluating Pathophysiological Mechanisms of Acute and Chronic Heat Stress on Maternal and Fetal Health (GaHPS)

U

University of Thessaly

Status

Completed

Conditions

Thermally Neutral Condition With Light-intensity Work
Warm Condition With Light-intensity Work
Warm Condition With Moderate-intensity Work
Thermally Neutral Condition With Moderate-intensity Work

Treatments

Other: Heat and Physical Work Exposure Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT07326176
GaHPS
227176/Z/23/Z (Other Grant/Funding Number)

Details and patient eligibility

About

This study examined the effects of environmental heat and physical work on maternal thermoregulation and fetal physiology in late pregnancy. Twenty-four healthy pregnant women at 28-32 weeks of gestation completed four randomized and counterbalanced 3-hour experimental scenarios combining two thermal conditions (temperate 20 °C and warm 30 °C, both at 45% relative humidity, shaded) and two physical workload intensities (light and moderate treadmill walking). Each scenario included 1 hour of passive seated exposure, 1 hour of treadmill walking, and 1 hour of seated recovery. Maternal thermoregulatory, cardiovascular, perceptual, and hydration responses were monitored continuously, while fetal heart rate and Doppler-derived indices of uterine, umbilical, and middle cerebral artery blood flow were assessed at baseline, end of passive exposure, end of work, and end of recovery. The aims of the study were: (1) to characterize maternal physiological and perceptual responses to heat exposure and physical work; (2) to determine whether maternal physiological heat strain directly affects fetal cardiovascular strain and maternal-fetal hemodynamics; and (3) to examine whether maternal characteristics, particularly body mass index and age, influence maternal thermoregulatory responses and fetal susceptibility to heat stress.

Enrollment

24 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy pregnant women between 28 and 32 weeks of gestation
  • Singleton pregnancy
  • Habitually heat-acclimatized, defined as daily exposure to outdoor environmental conditions equal to or warmer than those used in the study
  • Able to perform treadmill walking at light and moderate intensities
  • Willing and able to attend all laboratory sessions
  • Provided written informed consent
  • Age 18 years or older

Exclusion criteria

  • Multiple pregnancy (e.g., twins, triplets)

  • Chronic medical conditions, including but not limited to:

    • Hypertension
    • Diabetes
    • HIV
  • Obstetric complications, including:

    • Pre-eclampsia
    • Severe anemia
  • Acute infections, including urinary tract infection

  • Any contraindication to exercise based on the Physical Activity Readiness for Pregnancy (PARmed-X for Pregnancy) checklist

  • Inability to comply with the study procedures or scheduled visits

  • Any condition deemed by investigators to compromise participant safety or data integrity

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 4 patient groups

Temperate-Light
Other group
Description:
Participants were exposed to a temperate environment (20 °C, 45% relative humidity, shaded) for a 3-hour protocol consisting of 1 hour passive seated exposure, 1 hour of light-intensity treadmill walking (alternating between 2 and 3 METs \[Metabolic Equivalents\] every 10 minutes), and 1 hour seated recovery.
Treatment:
Other: Heat and Physical Work Exposure Protocol
Temperate-Moderate
Other group
Description:
Participants were exposed to a temperate environment (20 °C, 45% relative humidity, shaded) for a 3-hour protocol consisting of 1 hour passive seated exposure, 1 hour of moderate-intensity treadmill walking (alternating between 3 and 4 METs every 10 minutes), and 1 hour seated recovery.
Treatment:
Other: Heat and Physical Work Exposure Protocol
Warm-Light
Other group
Description:
Participants were exposed to a warm environment (30 °C, 45% relative humidity, shaded) for a 3-hour protocol consisting of 1 hour passive seated exposure, 1 hour of light-intensity treadmill walking (alternating between 2 and 3 METs every 10 minutes), and 1 hour seated recovery.
Treatment:
Other: Heat and Physical Work Exposure Protocol
Warm-Moderate
Other group
Description:
Participants were exposed to a warm environment (30 °C, 45% relative humidity, shaded) for a 3-hour protocol consisting of 1 hour passive seated exposure, 1 hour of moderate-intensity treadmill walking (alternating between 3 and 4 METs every 10 minutes), and 1 hour seated recovery.
Treatment:
Other: Heat and Physical Work Exposure Protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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