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Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)
Led by Aga Khan University · Updated on 2025-12-03
6000
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how exposure to high environmental temperatures during pregnancy affects the health of pregnant women and their babies in rural Sindh, Pakistan. The study aims to understand how heat stress impacts pregnancy complications and birth outcomes like early birth or low birth weight. It also explores biological pathways through which heat affects maternal, fetal, and infant health, considering factors such as socio-demographics and nutrition. This observational study enrolls pregnant women in their first trimester (under 14 weeks) and follows them through pregnancy and up to 12 months after birth. Participants wear devices measuring temperature and humidity, and some wear additional sensors to track skin temperature, heart rate, physical activity, and sleep. Researchers perform ultrasounds, collect blood and urine samples, and use questionnaires about heat exposure and coping strategies. After delivery, data on newborn size, birth timing, and complications are collected, along with placental and breastmilk samples for a subset. During the study, women attend clinic visits in the second and third trimesters for ongoing assessments. Researchers monitor heat exposure, physiological stress, hydration, and pregnancy progress through repeated ultrasounds and lab tests. The mother-infant pairs are followed monthly for a year to track health, growth, feeding, immunization, and development. The primary outcomes include low birth weight and small vulnerable newborns, with safety monitored throughout. This research will help inform protections for pregnant women and infants against climate-related heat risks in low-resource settings.
CONDITIONS
Brief Title
Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Single or multiple live pregnancy confirmed through ultrasound
- Gestational age less than or equal to 13 weeks and 6 days at enrollment
- At least 18 years of age
- Permanent resident of the study district and plans to deliver within the district
- Willing and able to attend study clinic visits and comply with study procedures throughout pregnancy
You will not qualify if you...
- Plan to relocate outside the district for more than 3 months during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From enrollment in first trimester through delivery (up to ~6 to 8 months)
Participants are monitored throughout pregnancy with regular assessments including ultrasounds, biological sample collection, and environmental heat exposure monitoring using wearable devices.
Multiple visits including ultrasounds at 12-14, 18-22, 28-32, and 36-37 weeks' gestation, plus periodic biological sample collections and continuous environmental monitoring
Duration - At time of delivery
Participants undergo delivery where newborn measurements and sample collections are performed shortly after birth.
1 delivery visit with newborn measurements within 48 hours
Duration - Up to 12 months postpartum
Participants and their newborns are followed for 12 months postpartum to assess growth, health, and development with monthly assessments.
Monthly visits for up to 12 months after delivery
Trial Site Locations
Total: 3 locations
1
Matiari Research and Training Centre
Matiari, Sindh, Pakistan
Actively Recruiting
2
Mithi Study Site Office
Mithi, Sindh, Pakistan
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3
Tando Muhammad Khan (TMK) Study Site Office
Tando Muhammad Khan, Sindh, Pakistan
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Research Team
J
Jai K Das, MBBS, PhD Public Health
A
Asma A Malik, MBBS, MSc Epi & Biostats
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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