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

NCT07312227 | Active Not Recruiting

• 1 other identifier: PregHigh
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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, and a hospitalized cohort of symptomatic women with pregnancies complicated by obstetric conditions (e.g., preeclampsia), 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 such as preeclampsia, pulmonary arterial hypertension, and right ventricular dysfunction.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Pulmonary artery pressures

  Measurement will be performed by transthoracic echocardiography.

  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

  Measurement will be performed with a chemiluminescence assay.

  Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks) for maternal samples, at delivery (neonatal samples)

• RV remodeling echocardiography parameters

  Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)

• Weight at birth

  At delivery

Study Arms (2)

Healthy pregnant women residing at high altitude

Women with uncomplicated pregnancy.

Symptomatic pregnant women residing at high altitude

Women with pregnancy complicated by obstetric conditions such as hypertensive disorders of pregnancy. Hospitalized.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The two cohorts will be selected from pregnant women who have lived at an altitude greater than 3500 meters throughout pregnancy and at delivery.

You may qualify if:

• singleton pregnancy
• women delivering at participating hospitals at more than 3500 meters
• signed informed consent

You may not qualify if:

• multiple pregnancy
• preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA \> III)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Hospital De La Meujer

La Paz, Bolivia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal urine, blood samples, umbilical cord blood samples, placental tissue

MeSH Terms

Conditions

Toxemia; Pulmonary Arterial Hypertension; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Infections; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorenzo Berra, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

BO (1)