Skip to content

A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia

A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07312227
Enrollment
27
Registered
2025-12-31
Start date
2026-02-11
Completion date
2027-02-01
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disorder of Pregnancy, Intrauterine Growth Restriction, Pulmonary Arterial Hypertension

Brief summary

In this study, the investigators will follow two small cohorts of pregnant women: a cohort of healthy women with uncomplicated pregnancies residing at high altitude, a control group of healthy women with uncomplicated pregnancies residing at sea level, to characterize differences in cardiopulmonary adaptation and nitric oxide (NO) pathway expression at elevations \>3,500 m throughout pregnancy and into the postpartum period. The investigators aim to investigate right-sided cardiac impairment induced by chronic hypobaric hypoxemia, its effects on fetal growth, and the potential contribution of cardiovascular nitric oxide depletion to obstetric complications.

Detailed description

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary artery pressuresLate pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)Measurement will be performed by transthoracic echocardiography.
Echographic estimate of fetal weightLate pregnancy (35 ± 4 weeks gestation)
Nitric oxide metabolitesLate pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks) for maternal samples, at delivery (neonatal samples)Measurement will be performed with a chemiluminescence assay.
RV remodeling echocardiography parametersLate pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)
Weight at birthAt delivery

Countries

Bolivia, United States

Contacts

CONTACTLorenzo Berra, MD
lberra@mgh.harvard.edu617-726-3030
CONTACTAndrea Bolchini, MD
abolchini@mgh.harvard.edu617-216-5124
PRINCIPAL_INVESTIGATORLorenzo Berra, MD

Massachusetts General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026