A Prospective Longitudinal Observational Cohort Study of Pregnant Women Residing at High Altitude in Bolivia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertensive Disorder of Pregnancy, Pulmonary Arterial Hypertension, Intrauterine Growth Restriction. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Bolivia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Pulmonary artery pressures [Time frame: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)]
- Echographic estimate of fetal weight [Time frame: Late pregnancy (35 ± 4 weeks gestation)]
- Nitric oxide metabolites [Time frame: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks) for maternal samples, at delivery (neonatal samples)]
- RV remodeling echocardiography parameters [Time frame: Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)]
- Weight at birth [Time frame: At delivery]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Bolivia · 1 center
- Hospital De La Meujer — La Paz
Identifiers
NCT: NCT07312227 · PregHigh