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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

women delivering at participating hospitals at more than 3500 meters or women delivering at participating hospitals at sea level

signed informed consent

Disqualifiers

preexisting cardiopulmonary pathologies (CHD, COPD, CKD, NYHA > III)

Trial population

The cohort of healthy pregnant women residing at high altitude will selected from pregnant women who have lived at an altitude greater than 3500 meters throughout pregnancy and at delivery. The control group will be pregnant women who have lived at sea level throughout pregnancy and at delivery.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

27 Participants
are grouped into 2 trial groups
Group A: Healthy pregnant women residing at high altitude
Group B: Healthy pregnant women residing at sea level

Trial outcomes

Primary outcomes

1

Pulmonary artery pressures

Measurement will be performed by transthoracic echocardiography.

Time frame
Late pregnancy (35 ± 4 weeks gestation) and postpartum (6 ± 0.3 weeks)
2

Echographic estimate of fetal weight

Time frame
Late pregnancy (35 ± 4 weeks gestation)
3

Nitric oxide metabolites

Measurement will be performed with a chemiluminescence assay.

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

RV remodeling echocardiography parameters

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.