RecruitingNot Applicable

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

United States, Bolivia27 participantsStarted 2026-02-11

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pulmonary artery pressures

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

Echographic estimate of fetal weight

Timeframe: Late pregnancy (35 ± 4 weeks gestation)

Nitric oxide metabolites

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

RV remodeling echocardiography parameters

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

Weight at birth

Timeframe: At delivery

Trial details

NCT IDNCT07312227

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Lorenzo Berra, MD

617-726-3030 lberra@mgh.harvard.edu

View on ClinicalTrials.gov More Hypertensive Disorder of Pregnancy trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pulmonary artery pressures

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

Echographic estimate of fetal weight

Timeframe: Late pregnancy (35 ± 4 weeks gestation)

Nitric oxide metabolites

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

RV remodeling echocardiography parameters

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

Weight at birth

Timeframe: At delivery