Continuous Positive Airway Pressure (CPAP)
DeviceA non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
NCT Number: NCT03356106
This is an open-label multicenter randomized-controlled trial in 3 tertiary care hospitals including Ramathibodi Hospital, Phramongkutklao Hospital and Rajavithi Hospital. The study involved screening of obstructive sleep apnea in high risk pregnancy during 1st and 2nd trimesters. Randomization to either continuous positive airway pressure (CPAP) or usual antenatal care (ANC) until delivery will be done. Efficacy of CPAP on pregnancy outcome will be analysed.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Phramongkutklao Hospital, Bangkok, Thailand
Screening for sleep disordered breathing (Respiratory disturbance index, RDI ≥ 5 events/hour) with type 2 sleep test will be performed in eligible subjects during early1st trimester (<16 weeks). Repeat sleep study will be done if the RDI in 1st trimester is less than 5. If the subjects meet the inclusion criteria without any of the exclusion criteria, randomization into either receiving CPAP treatment or usual ANC will be done. The pressure of CPAP machine is determined using autoCPAP machine algorithm at 90 percentile. Adjustment of CPAP machine is repeated at 24-28 week gestations. Subjects in both groups received standard usual care during ANC and outcomes were measured with similar case record forms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
High risk pregnant women attending the antenatal care at the collaborated hospitals will be eligible for the study if they meet all following inclusion criteria.
Inclusion criteria
(ALL criteria)
Exclusion criteria
A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
Time frame: During 24-28 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: During 32-34 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: During 24-28 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time frame: During 32-34 weeks gestation
Difference of daytime mean blood pressure between 2 groups(mmHg)
Time frame: During 18-20 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time frame: During 18-20 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: measured twice during 24-28 week gestation, and 32-34 week gestation
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Time frame: measured twice during 32-34 week gestation
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Time frame: During pregnancy until delivery
Incidence of hypertensive disorder of pregnancy
Time frame: During pregnancy until delivery
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section
Time frame: During pregnancy until delivery
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death
Time frame: during 24-28 weeks gestation
Fasting plasma glucose (mg/dL)
Time frame: during 32-34 weeks gestation
Fasting plasma glucose (mg/dL)
Time frame: during 24-28 weeks gestation
Oral Glucose Tolerance Test (OGTT) (mg/dL)
Time frame: During 24-28 weeks gestation
Fetal growth (grams)
Time frame: During 32-34 weeks gestation
Fetal growth (grams)
Time frame: During 18-20 weeks gestation
Uterine Doppler arterial blood flow
Time frame: During 24-28 weeks gestation
Uterine Doppler arterial blood flow
Time frame: During 32-34 weeks gestation
Uterine Doppler arterial blood flow
Time frame: at delivery
Neonatal birthweight (grams)
Time frame: at 1 minute and 5 minutes after birth
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Time frame: Through study completion up to 24 weeks
Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital
Time frame: Through study completion up to 24 weeks
Neonatal ICU admission rate (%) after birth
Ramathibodi Hospital
Other
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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