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NCT03248219 · ClinicalTrials.gov registry record
The Sleep in Pregnancy Study
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 19
- Enrollment target
NCT03248219: Completed study, sponsored by University of Colorado, Denver.
NCT03248219 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03248219 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study 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 restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are common during pregnancy, SDB remains under-recognized, under-diagnosed, and poorly understood, particularly in pregnancies affected by obesity. Sixty percent of pregnancies are now affected by obesity, yet the relationship between SDB, patterns of glycemia, and insulin resistance (IR) in obese pregnant women is a neglected area with major therapeutic implications to improve maternal and infant health. Using a prospective design in which diet and gestational age are highly controlled, the investigators propose to measure SDB (apneas/hypopneas) in obese pregnant women using an ambulatory sleep monitoring system. In parallel, robust patterns of glycemia will be measured with a continuous glucose monitoring system (CGMS), followed by a 75g oral glucose tolerance test to measure insulin action. The investigators global hypothesis is that worse SDB in part accounts for higher 24-hour patterns of glycemia in obese normal glucose tolerant (NGT) pregnant women in their 3rd trimester. The Investigators will test the hypothesis that: 1) In obese NGT pregnant women at 32-34 weeks gestation on a controlled eucaloric diet, higher apnea hypopnea index (AHI) will be positively associated with 24-hour glycemia measured by a CGMS and that, 2) Higher AHI in obese NGT pregnant women at 32-34 weeks gestation on a eucaloric controlled diet will be associated with higher insulin resistance measured by a 75g oral glucose tolerance test (Matsuda Model). Early identification and treatment has the potential to decrease long-term maternal cardiovascular morbidity and mortality.
Primary Outcome
Glycemia will be measured by Continuous glucose monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2018-03-20 |
What the finished NCT03248219 record still lists
NCT03248219 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03248219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03248219 about?
NCT03248219 is a clinical study titled "The Sleep in Pregnancy Study". Sleep disordered breathing (SDB) insidiously worsens metabolic function, heightens insulin resistance (IR), and in pregnancy is thought to precipitate gestational diabetes, preterm birth, growth restriction, gestational hypertension, and preeclampsia. Despite the fact that sleep disturbances are com...
What is the current status of trial NCT03248219?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2017-03-15. Estimated completion is 2018-03-20.
Who is sponsoring clinical trial NCT03248219?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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