Effects of High Altitude on AMPK Activation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Colorado, Denver
About this trial
Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high altitude and may contribute to the observed 3-fold increase in intrauterine growth restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m)
Cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation
Disqualifiers
Women will be excluded if there are co-existing medical diagnoses that are known to affect vascular parameters (i.e., diabetes mellitus, gestational diabetes, any hypertensive disorder of pregnancy, or a current smoker).
Women with multiple gestations and preterm deliveries will also be excluded.
Trial population
Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m) will be identified. In order to avoid any possible confounding effects of labor or prematurity, only women with elective cesarean deliveries will be approached for enrollment (cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Collection of myometrial, cord blood, and placental tissue samples
Procedure/SurgeryWe propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA).
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: High Altitude (3000 m)1 intervention
Group B: Low Altitude (1600 m)1 intervention
Trial outcomes
Primary outcomes
1
Changes in Myometrial artery dimensions
Myometrial artery dimensions as quantified by immunohistochemistry or other staining techniques, and results of studies of isolated myometrial artery studies in which vasoconstrictor and vasodilator responses to pharmacological agonists are measured using absolute values and the percent maximal contraction to potassium chloride.
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov