Actively Recruiting
A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
Led by Massachusetts General Hospital · Updated on 2026-05-26
27
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of living at high altitude during pregnancy by following two groups of healthy pregnant women: one group residing at elevations above 3,500 meters and another residing at sea level. The study aims to understand how chronic low oxygen levels at high altitudes affect heart function, especially the right side of the heart, fetal growth, and the role of nitric oxide in pregnancy complications related to blood vessel and heart function. The study involves detailed heart ultrasound examinations to assess right heart anatomy and function, including measurements of pulmonary artery pressure and right ventricular performance. Researchers will also track fetal growth before and after birth, examine placental characteristics, and measure nitric oxide-related substances in maternal blood, umbilical cord blood, and placental tissue. These assessments will be correlated with oxygen levels and altitude exposure. Flow-mediated dilation tests will be performed in the high altitude group to evaluate blood vessel function. Participants will be monitored through late pregnancy (around 35 weeks) and into the postpartum period (about 6 weeks after delivery). Researchers will collect data on heart and fetal measurements, nitric oxide levels, and birth weight. This comprehensive monitoring aims to clarify how high altitude impacts cardiovascular health and fetal development during and after pregnancy, with ongoing follow-up until postpartum.
CONDITIONS
Brief Title
A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women delivering at participating hospitals at more than 3500 meters or at sea level
- Signed informed consent
You will not qualify if you...
- Preexisting cardiopulmonary pathologies such as congenital heart disease, chronic obstructive pulmonary disease, chronic kidney disease, or New York Heart Association class III or higher
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 visit (in-person)
Duration - Around late pregnancy (approximately 31 to 39 weeks gestation)
Participants undergo transthoracic echocardiography and blood sampling to assess cardiac function, pulmonary artery pressures, nitric oxide metabolites, and fetal growth parameters during late pregnancy.
1 visit (in-person) at late pregnancy (35 ± 4 weeks gestation)
Duration - At delivery
Participants have assessments at delivery including fetal weight measurement, placental examination, and neonatal blood sampling for nitric oxide metabolites.
1 visit (in-person) at delivery
Duration - About 6 weeks postpartum (6 ± 0.3 weeks)
Participants are monitored postpartum to assess cardiac function, pulmonary artery pressures, and nitric oxide metabolites.
1 visit (in-person) postpartum
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Hospital De La Meujer
La Paz, Bolivia
Completed
Research Team
L
Lorenzo Berra, MD
A
Andrea Bolchini, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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