Skip to content

The Sleep in Pregnancy Study

Sleep Disordered Breathing Accounts for Abnormal Glycemic Profiles in Pregnant Women: The Sleep in Pregnancy (SiP) Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03248219
Acronym
SiP
Enrollment
19
Registered
2017-08-14
Start date
2017-03-15
Completion date
2018-03-20
Last updated
2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pregnancy Related, Sleep Disordered Breathing

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 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.

Interventions

None listed

Sponsors

Colorado Clinical & Translational Sciences Institute
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women: 1. Between the ages of 20-39 yrs, 2. At 32-34 weeks gestation, 3. Who have a BMI of ≥30 to ≤40 kg/m2, 4. Who have a singleton pregnancy, and 5. Who have a normal glucose tolerance test on entrance to the study.

Exclusion criteria

* Pregnant Women: 1. Who have a diagnosis of diabetes (GDM, type 1 or type 2), 2. Who are using beta blockers/glucocorticoids. 3. Who have other children who are ≤2 yrs old (due to risk of disrupted sleep), 4. With diagnosed sleep disorders (e.g. OSA, insomnia, restless leg syndrome), 5. Who work night or rotating shifts, 6. Who report use of sleep medications will be excluded, 7. With diagnosed pulmonary or cardiovascular disease 8. Who do not speak English.

Design outcomes

Primary

MeasureTime frameDescription
24 hour glycemia measurement of the Pregnant MotherEvery 24 hours for 3 daysGlycemia will be measured by Continuous glucose monitoring
Evaluation of Insulin resistance of the Pregnant Mother2 hours after a 75 gram glucose loadInsulin resistance will be measured with an Oral Glucose Tolerance Test

Secondary

MeasureTime frameDescription
Infant Body CompositionAt 2 weeks of lifePercent of Fat Mass
Stress Levels15 minutes before Sleep and 15 minutes after sleepCortisol Levels

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026