Status:
COMPLETED
The Sleep in Pregnancy Study
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Colorado Clinical & Translational Sciences Institute
Conditions:
Pregnancy Related
Sleep Disordered Breathing
Eligibility:
FEMALE
20-39 years
Brief Summary
Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restr...
Eligibility Criteria
Inclusion
- Pregnant women:
- Between the ages of 20-39 yrs,
- At 32-34 weeks gestation,
- Who have a BMI of ≥30 to ≤40 kg/m2,
- Who have a singleton pregnancy, and
- Who have a normal glucose tolerance test on entrance to the study.
Exclusion
- Pregnant Women:
- Who have a diagnosis of diabetes (GDM, type 1 or type 2),
- Who are using beta blockers/glucocorticoids.
- Who have other children who are ≤2 yrs old (due to risk of disrupted sleep),
- With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome),
- Who work night or rotating shifts,
- Who report use of sleep medications will be excluded,
- With diagnosed pulmonary or cardiovascular disease
- Who do not speak English.
Key Trial Info
Start Date :
March 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2018
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03248219
Start Date
March 15 2017
End Date
March 20 2018
Last Update
June 20 2018
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045