A pilot randomised controlled trial on the effect of Continuous Positive Airway Pressure (CPAP) or positional therapy on the development of gestational diabetes in obstructive sleep apnoea in pregnancy.

South West Sydney Local Health District0 sites48 target enrollmentNovember 6, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 6, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

Female

Sponsor

South West Sydney Local Health District

•1\.Early pregnancy (less than 14 weeks from last menstrual period)
•2\.Increased risk defined as ONE OR MORE of:
•a.Body mass index greater than or equal to 35 kg/m2
•b.Previous gestational diabetes mellitus (GDM)
•c.Previous personal history of pre\-eclampsia (or in mother or sister)
•d.Underlying renal disease
•e.Maternal type 2 diabetes (pre\-gestational)
•f.Symptoms of sleep\-disordered breathing including snoring, witnessed apnoeas, mild excessive daytime sleepiness (which does not meet the criteria for severe excessive daytime sleepiness) or tiredness.
•g. Obstructive sleep apnoea diagnosed on in\-lab polysomnography, based on the respiratory disturbance index (RDI) of greater than or equal to 5\.

•1\.Previous diagnosis of sleep disordered breathing on active treatment
•2\.Confirmed GDM or pre\-eclampsia
•3\.Maternal type 1 diabetes
•4\.Multifoetal gestation
•5\.Known foetal chromosomal abnormality
•6\.Inability to provide informed consent
•7\. Severe EDS based on clinical assessment (eg including a fall asleep MVA or near miss, transient sleepiness while driving/at lights or needing to pull over due to sleepiness while driving, or transient sleepiness in any other dangerous situation ie cooking, carrying baby) or Epworth Sleepiness Scale of greater than 15\.