Cardiac and fetal health in pregnancy at high altitude

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, longitudinal observational study follows two cohorts of pregnant women: those at high altitude residences (>3,500 meters) and a sea-level control group, with aims to describe cardiopulmonary adaptation and nitric oxide pathway activity throughout pregnancy and postpartum. Researchers will use transthoracic echocardiography to evaluate right-sided heart structure and function, including pulmonary pressures and right ventricular performance, and will measure NO-related biomarkers in maternal blood, cord blood, and placental tissue. They will also examine fetal growth parameters, placental characteristics, and endothelial function via flow-mediated dilation, correlating findings with altitude exposure and maternal oxygenation. The study is observational and does not specify interventions, focusing on associations between altitude-related hypoxia and obstetric outcomes. Eligibility includes pregnant women delivering at participating high-altitude or sea-level hospitals, excluding those with major preexisting cardiopulmonary diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* women delivering at participating hospitals at more than 3500 meters or women delivering at participating hospitals at sea level
* signed informed consent

Exclusion Criteria:

* preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA \> III)

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Hospital De La Meujer
  La Paz, Bolivia Completed

Study contacts

• Principal investigator: Lorenzo Berra, MD — Massachusetts General Hospital
• Study coordinator: Lorenzo Berra, MD
• Email: lberra@mgh.harvard.edu
• Phone: 617-726-3030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.