RecruitingRecruiting
A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
NCT07312227 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
To investigate cardiac impairment, the investigators will perform transthoracic echocardiography in all enrolled pregnant women and infants, with a focus on right-sided cardiac anatomy and function, including pulmonary artery pressures, right ventricular thickness, right ventricular systolic performance, and indices of pulmonary vascular load.
To investigate the effects of hypobaric hypoxia on fetal growth, the investigators will measure intrauterine and post-delivery growth parameters, assess placental weight and histologic features, and correlate these findings with maternal oxygenation status and altitude exposure.
To assess nitric oxide production and consumption, the investigators will quantify nitric oxide-related metabolites (NO metabolomics) in maternal blood, umbilical cord blood, and placental tissue in both cohorts, and correlate these biomarkers with pulmonary arterial pressures, and right ventricular function. The investigators will also assess flow-mediated dilation in the high altitude cohort and relate these measures of endothelial function to pulmonary vascular and obstetric outcomes.
Eligibility criteria
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)
Study design
Enrollment target: 27 participants
Age groups: adult
Timeline
Starts: 2026-02-11
Estimated completion: 2027-02
Last updated: 2026-05-26
Primary outcomes
- • Pulmonary artery pressures (Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks))
- • Echographic estimate of fetal weight (Late pregnancy (35 ± 4 weeks gestation))
- • Nitric oxide metabolites (Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks) for maternal samples, at delivery (neonatal samples))
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactLorenzo Berra, MD · contact · lberra@mgh.harvard.edu · 617-726-3030
ContactAndrea Bolchini, MD · contact · abolchini@mgh.harvard.edu · 617-216-5124
InvestigatorLorenzo Berra, MD · principal_investigator, Massachusetts General Hospital
All locations (2)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Hospital De La MeujerCompleted
La Paz, Bolivia