Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07312227

Conditions

Hypertensive Disorder of Pregnancy

Pulmonary Arterial Hypertension

Intrauterine Growth Restriction

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Hypertensive Disorder of Pregnancy

Pulmonary Arterial Hypertension

Intrauterine Growth Restriction

Study ID

NCT07312227

Start date

Feb 11, 2026

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

27 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy pregnant women residing at high altitude

Women with uncomplicated pregnancy.

Healthy pregnant women residing at sea level

Women with uncomplicated pregnancy.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Lorenzo Berra, MD

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

Andrea Bolchini, MD

617-216-5124abolchini@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-26.