Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial

Conditions
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Sleep Apnea, Obstructive, Pre-Eclampsia, Hypertension, Pregnancy-Induced

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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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) Singleton pregnant women age ≥ 18 years Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age < 16 weeks Thai nationality with ability to use Thai language proficiently both in spoken and written language. Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions Chronic hypertension prior to pregnancy Hypertension during pregnancy before 20 weeks gestation. Pre-eclampsia/gestational hypertension during recent pregnancy Obesity defined by pre-pregnancy body mass index (BMI) ≥ 27.5 kg/m2 History of diabetes mellitus or gestational diabetes Having gestational diabetes or overt diabetes Presence of snoring (either as frequent snoring ≥3 times/week or loud snoring) prior to or occurring during pregnancy OR respiratory disturbance index, RDI ≥ 5 events/hour by type 2 sleep testing at either point of testing during early pregnancy (0-16 GA week) or late pregnancy (GA 24-28week ). Sign written informed consent Exclusion Criteria: Subjects' unwillingness to participate in the study at any time of the study. Subject with significant medical conditions such as immunocompromised status, chronic infection (HIV infection, tuberculosis), chronic lung and cardiac conditions, chronic renal failure, thyroid disease, or neuromuscular disease. Subjects with extremely severe obstructive sleep apnea (RDI ≥30) or with significant O2 desaturation <80% during sleep that might have potential benefit from the CPAP treatment. Subject with known obstructive sleep apnea and currently on CPAP treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery | Device: Continuous positive airway pressure (CPAP)<br>* A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep<br>|
| No Intervention: Control<br>Usual antenatal care for high risk pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 24-28 weeks gestation | 
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 32-34 weeks gestation | 
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups (mmHg) | During 24-28 weeks gestation | 
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups(mmHg) | During 32-34 weeks gestation | 
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups (mmHg) | During 18-20 weeks gestation | 
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 18-20 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour ambulatory blood pressure monitoring | Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg) | measured twice during 24-28 week gestation, and 32-34 week gestation | 
| 24-hour ambulatory blood pressure monitoring | Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg) | measured twice during 32-34 week gestation | 
| Incidence of pregnancy induced hypertension (composite outcome1) | Incidence of hypertensive disorder of pregnancy | During pregnancy until delivery | 
| Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2) | Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section | During pregnancy until delivery | 
| Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3) | Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death | During pregnancy until delivery | 
| Fasting plasma glucose | Fasting plasma glucose (mg/dL) | during 24-28 weeks gestation | 
| Fasting plasma glucose | Fasting plasma glucose (mg/dL) | during 32-34 weeks gestation | 
| Oral glucose tolerance test (OGTT) | Oral Glucose Tolerance Test (OGTT) (mg/dL) | during 24-28 weeks gestation | 
| Fetal ultrasound results | Fetal growth (grams) | During 24-28 weeks gestation | 
| Fetal ultrasound results | Fetal growth (grams) | During 32-34 weeks gestation | 
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 18-20 weeks gestation | 
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 24-28 weeks gestation | 
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 32-34 weeks gestation | 
| Neonatal birthweight | Neonatal birthweight (grams) | at delivery | 
| APGAR score | 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. | at 1 minute and 5 minutes after birth | 
| Neonatal length of stay in hospital | Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital | Through study completion up to 24 weeks | 
| Neonatal ICU admission rate | Neonatal ICU admission rate (%) after birth | Through study completion up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Pre-Eclampsia