The effect of treatment of obstructive sleep apnoea on the development of gestational diabetes in pregnancy (POSA).

Not Applicable

Recruiting

• Conditions: Obstructive sleep apnoea; Respiratory - Sleep apnoea; Metabolic and Endocrine - Diabetes; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Cardiovascular - Hypertension

• Registration Number: ACTRN12619001530112
• Lead Sponsor: South West Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-06
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

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.
AND
g. Obstructive sleep apnoea diagnosed on in-lab polysomnography, based on the respiratory disturbance index (RDI) of greater than or equal to 5.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational diabetes on oral glucose tolerance test[Oral glucose tolerance test at 28 weeks]