Actively Recruiting

Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID07312227

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

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women delivering at participating hospitals at more than 3500 meters or at sea level
  • Signed informed consent
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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