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A pilot study to assess the impact of obstructive sleep apnea (OSA) and treatment with continuous positive airway pressure (CPAP) therapy on maternal blood pressure and placental blood flow in high risk obstetric patients

A prospective cohort study to assess the impact of obstructive sleep apnea (OSA) and treatment with autotitrating continuous positive airway pressure (CPAP) therapy on maternal blood pressure and placental blood flow in severely obese obstetric patients

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001963213
Acronym
OSAP
Enrollment
5
Registered
2018-12-05
Start date
2019-01-02
Completion date
2019-12-28
Last updated
2026-09-07

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

Conditions

None listed

Brief summary

The study will follow a cohort of high risk pregnant women and assess for and treat OSA with CPAP therapy. Maternal blood pressure will be monitored throughout pregnancy and is the primary outcome between the two groups of participants (those with OSA compared with those without OSA). Quality of life will be assessed during pregnancy to determine if treating OSA improves quality of life. Placental vascular health will be monitored via ultrasound assessment at 28, 32 and 36 weeks gestational age followed by pathological examination of the placenta following delivery. Those women with a diagnosis of OSA during pregnancy will be reassessed for persistence of OSA at 6 months post partum.

Interventions

Autotitrating continuous airway pressure (CPAP) will be prescribed from a pressure of 4-20 cm H2O, for a minimum of 4 hours per night, to all pregnant women diagnosed with obstructive sleep apnea (as defined by an apnea-hypopnea index (AHI) of >10/hr) following a diagnostic polysomnogram and consultation with a sleep physician. Compliance to treatment will be individualized and assessed on a weekly basis by the sleep physician with the assistance of the sleep nurse and CPAP provider. Treatment

Autotitrating continuous airway pressure (CPAP) will be prescribed from a pressure of 4-20 cm H2O, for a minimum of 4 hours per night, to all pregnant women diagnosed with obstructive sleep apnea (as defined by an apnea-hypopnea index (AHI) of >10/hr) following a diagnostic polysomnogram and consultation with a sleep physician. Compliance to treatment will be individualized and assessed on a weekly basis by the sleep physician with the assistance of the sleep nurse and CPAP provider. Treatment with CPAP therapy will continue from the time of diagnosis of OSA up until 6 months post-partum following a repeat diagnostic sleep study.

Sponsors

Flinders Medical Centre
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Early pregnancy BMI of 35 kg/m2 or more Gestational age less than 28 weeks Ability to given informed consent

Exclusion criteria

Lack of regular attendance at clinic appointments Illicit or intravenous drug use Current cigarette smoking Known diagnosis of OSA already established on CPAP therapy Type 1 diabetes mellitus Pulmonary hypertension cardiomyopathy

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026