Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)

Summary

The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study also aims to understand how the body responds to heat stress during pregnancy and how this might lead to pregnancy complications and birth problems like early birth or low birth weight.

The main questions that the study aims to answer are:

1. What are the acute and chronic effects of environmental heat exposure on pregnancy and birth outcomes across different trimesters?
2. Through which biological pathways does heat stress impact maternal, fetal, and infant health across varying gestational ages?
3. How do socio-demographic factors, maternal characteristics, and nutritional status of women modify the relationship between environmental heat exposure and adverse pregnancy outcomes?

The study will take place in rural parts of Sindh, Pakistan. These areas often experience extreme heat and have limited access to electricity or cooling systems like fans or air conditioners.

This study will include pregnant women who are in their first trimester (under 14 weeks of pregnancy). Before starting any study activities, researchers will explain the study to each woman in a language she understands and ask for her written permission to take part (informed consent).

At the beginning of the study, participants will visit a study clinic. During this visit, researchers will check their height and weight, perform an ultrasound, and collect a small amount of blood for testing. Participants will also be asked to wear a small device that measures the air temperature and humidity in their surroundings.

The researchers will follow each participant during her pregnancy, with visits during the second and third trimesters at the study clinic. At each visit, researchers will check how much heat the participant has been exposed to using the data from the device and from her own answers to a simple questionnaire. The questionnaire will have questions about their heat exposure at work, home, type of clothing, and how they deal with hot weather. Serial ultrasound, blood and urine tests will be conducted so researchers can study signs of stress, hydration, and other changes in the body. A smaller group of participants will also wear a device to measure their body skin temperature, heart rate, physical activity and sleep during pregnancy.

When the baby is born, researchers will collect information about the birth, including the baby's weight and length, the time of delivery, and whether there were any complications during birth. After delivery, both the mother and baby will be followed for up to 12 months. During this time, the research team will check the health of both the mother and baby and see how heat exposure during pregnancy may affect the baby's growth over time. At delivery, placental weight and volume will be collected for a smaller group of women. Breastmilk sampling will also be done for this group of women to understand the effect of high temperatures on breastmilk quality.

This study does not involve any treatment or medicine. Instead, researchers will observe the participants to learn how real-life heat exposure affects them during pregnancy. The findings from this study may help public health officials and governments find better ways to protect pregnant women and babies from the harmful effects of climate change and extreme heat, especially in places with limited resources.

Conditions

• Low Birth Weight Baby
• Small for Gestational Age (SGA)
• Preterm Birth
• Pregnancy Complications
• Birth Outcome, Adverse
• Heat Strain
• Infant Morbidity
• Infant Mortality
• Neonatal Mortality

Interventions

OTHER

heat stress

Heat stress (exposure) will be quantified using validated environmental heat stress indices, including the mean Heat Index (HI). The heat index represents the apparent temperature or how hot it feels to the human body when air temperature is combined with relative humidity. Individual-level ambient temperature heat exposure will be assessed using wearable temperature and humidity loggers.

Sponsors & Collaborators

• Aga Khan University

  lead OTHER

Principal Investigators

• Jai K Das, MBBS, PhD Public Health · Aga Khan University

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-07

Primary Completion

2027-06-30

Completion

2028-06-30

Countries

• Pakistan

Study Locations