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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05908591
Other study ID # Pro00110658
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date August 2024

Study information

Verified date March 2024
Source University of Alberta
Contact Margie Davenport, PhD
Phone 780-492-0642
Email mdavenpo@ualberta.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 109
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18 years of age - pregnant (20-24 weeks gestation at enrollment) Exclusion Criteria: - worked shift work past 11pm in the previous month - previously diagnosed with a sleep disorder by a physician

Study Design


Locations

Country Name City State
Canada Program for Pregnancy and Postpartum Health, University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial Function The investigators will assess endothelial function using flow mediated dilation 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - arterial stiffness with pulse wave velocity The investigators will measure arterial stiffness using pulse wave velocity of the carotid and femoral arteries 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - arterial stiffness with beat-by-beat blood pressure The investigators will measure arterial stiffness using beat-by-beat blood pressure from the finger. 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - ambulatory blood pressure Blood pressure will be collected every 30 minutes during a 24-hour period using an ambulatory blood pressure monitor. 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - resting blood pressure Beat-by-beat blood pressure will be collected at rest. 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - heart rate Heart rate will be assessed by 3-lead ECG collected during sleep and at rest. 20-24 weeks and 28-36 weeks gestation
Secondary Cardiovascular Function - arrythmias Presence of arrythmias will be assessed by 3-lead ECG collected during sleep and at rest. 20-24 weeks and 28-36 weeks gestation
Secondary Maternal outcome - dietary intake Participants will complete two 3-day food logs. 20-24 weeks and 28-36 weeks gestation
Secondary Fasted blood sample - blood viscosity Fasted blood samples will be analyzed using a viscometer. 20-24 weeks and 28-36 weeks gestation
Secondary Fasted blood sample - presence of inflammatory markers Fasted blood samples will be analyzed for C-reactive protein. 20-24 weeks and 28-36 weeks gestation
Secondary Fasted blood sample - sex hormone levels Fasted blood samples will be analyzed for sex hormone levels (estrogen, progesterone, testosterone). 20-24 weeks and 28-36 weeks gestation
Secondary Fasted blood sample - metabolic Fasted blood samples will be analyzed for glucose and insulin concentration. 20-24 weeks and 28-36 weeks gestation
Secondary Maternal outcomes - delivery Participants will provide the investigators with information regarding delivery and pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia). 2 months postpartum
Secondary Fetal outcomes at delivery - infant sex Participants will provide the investigators with information regarding infant sex. 2 months postpartum
Secondary Fetal outcomes at delivery - birth weight Participants will provide the investigators with information regarding infant birth weight. 2 months postpartum
Secondary Fetal outcomes at delivery - birth length Participants will provide the investigators with information regarding birth length. 2 months postpartum
Secondary Fetal outcomes at delivery - gestational age Participants will provide the investigators with information regarding gestational age at delivery. 2 months postpartum
Secondary Fetal outcomes at delivery - birth mode Participants will provide the investigators with information regarding birth mode. 2 months postpartum
Secondary Fetal outcomes at delivery - apgar score Participants will provide the investigators with information regarding infant apgar score at delivery. 2 months postpartum
Secondary Fetal outcomes at delivery - time spent in NICU Participants will provide the investigators with information regarding infant time spent in neonatal intensive care unit (NICU). 2 months postpartum
Secondary Maternal outcome - amount of activity Participants will wear two accelerometers to measure the amount of physical activity performed. 20-24 weeks and 28-36 weeks
Secondary Maternal outcome - Mood - State-Trait Anxiety Inventory Participants will complete the State-Trait Anxiety Inventory to measure mood. 20-24 weeks and 28-36 weeks
Secondary Maternal outcome - Mood - Edinburgh Postnatal Depression Scale Participants will complete the Edinburgh Postnatal Depression Scale to measure mood. 20-24 weeks and 28-36 weeks
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