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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 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 19 participants.

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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.

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2017-03-15
Est. Completion 2018-03-20

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT03248219

The ClinicalTrials.gov registry entry for NCT03248219 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT03248219 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.