Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy
- Conditions
- Sleep-Disordered BreathingPregnancy Related
- Registration Number
- NCT05908591
- Lead Sponsor
- University of Alberta
- Brief Summary
This is a prospective longitudinal cohort study whereby pregnant individuals are asked to complete an 8-day testing protocol to measure their sleep and cardiovascular health at two timepoints during pregnancy.
- Detailed Description
The goal of this observational study is to examine the effect of sleep disordered breathing on the health of the heart and blood vessels of the mother during pregnancy. The main questions it aims to answer are:
* Is sleep disordered breathing associated with impaired the function of the heart and blood vessels in pregnancy?
* Is higher levels of physical activity associated with a reduced risk of sleep disordered breathing in pregnancy?
Participants will complete an 8 day long study protocol at two time points during pregnancy (20-24 weeks gestation and 28-36 weeks gestation). During each testing period they will be asked to:
* Complete one night of at-home sleep testing and and one night of overnight vital signs monitoring (ambulatory blood pressure and heart rate monitoring devices)
* Wear two accelerometers and complete a 7-day sleep log
* Complete a set of questionnaires
* Visit the laboratory for a fasted blood draw and ultrasound assessment of their cardiovascular health (resting heart rate and blood pressure, flow mediated dilation and pulse wave velocity tests)
Participants will also be asked to complete a short follow-up survey in the postpartum period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 109
- over 18 years of age
- pregnant (20-24 weeks gestation at enrollment)
- worked shift work past 11pm in the previous month
- previously diagnosed with a sleep disorder by a physician
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endothelial Function 20-24 weeks and 28-36 weeks gestation The investigators will assess endothelial function using flow mediated dilation
- Secondary Outcome Measures
Name Time Method Cardiovascular Function - resting blood pressure 20-24 weeks and 28-36 weeks gestation Beat-by-beat blood pressure will be collected at rest.
Fasted blood sample - blood viscosity 20-24 weeks and 28-36 weeks gestation Fasted blood samples will be analyzed using a viscometer.
Fasted blood sample - sex hormone levels 20-24 weeks and 28-36 weeks gestation Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone).
Maternal outcomes - delivery 2 months postpartum Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
Fetal outcomes at delivery - birth mode 2 months postpartum Participants will provide the investigators with information regarding birth mode.
Fetal outcomes at delivery - time spent in NICU 2 months postpartum Participants will provide the investigators with information regarding infant time spent in neonatal intensive care unit (NICU).
Maternal outcome - amount of activity 20-24 weeks and 28-36 weeks Participants will wear two accelerometers to measure the amount of physical activity performed.
Fetal outcomes at delivery - birth length 2 months postpartum Participants will provide the investigators with information regarding birth length.
Fetal outcomes at delivery - apgar score 2 months postpartum Participants will provide the investigators with information regarding infant apgar score at delivery.
Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure 20-24 weeks and 28-36 weeks gestation The investigators will measure arterial stiffness using beat-by-beat blood pressure from the finger.
Cardiovascular Function - heart rate 20-24 weeks and 28-36 weeks gestation Heart rate will be assessed by 3-lead ECG collected during sleep and at rest.
Maternal outcome - dietary intake 20-24 weeks and 28-36 weeks gestation Participants will complete two 3-day food logs.
Fasted blood sample - presence of inflammatory markers 20-24 weeks and 28-36 weeks gestation Fasted blood samples will be analyzed for C-reactive protein.
Fetal outcomes at delivery - birth weight 2 months postpartum Participants will provide the investigators with information regarding infant birth weight.
Cardiovascular Function - arterial stiffness with pulse wave velocity 20-24 weeks and 28-36 weeks gestation The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries
Cardiovascular Function - arrythmias 20-24 weeks and 28-36 weeks gestation Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest.
Fetal outcomes at delivery - infant sex 2 months postpartum Participants will provide the investigators with information regarding infant sex.
Cardiovascular Function - ambulatory blood pressure 20-24 weeks and 28-36 weeks gestation Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor.
Fasted blood sample - metabolic 20-24 weeks and 28-36 weeks gestation Fasted blood samples will be analyzed for glucose and insulin concentration.
Fetal outcomes at delivery - gestational age 2 months postpartum Participants will provide the investigators with information regarding gestational age at delivery.
Maternal outcome - Mood - State-Trait Anxiety Inventory 20-24 weeks and 28-36 weeks Participants will complete the State-Trait Anxiety Inventory to measure mood.
Maternal outcome - Mood - Edinburgh Postnatal Depression Scale 20-24 weeks and 28-36 weeks Participants will complete the Edinburgh Postnatal Depression Scale to measure mood.
Trial Locations
- Locations (1)
Program for Pregnancy and Postpartum Health, University of Alberta
🇨🇦Edmonton, Alberta, Canada