Hypertension, Pregnancy-Induced, Pre-Eclampsia, Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive sleep apnea, Pre-Eclampsia
Brief summary
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
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.
Interventions
DEVICEContinuous positive airway pressure (CPAP)
A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
Sponsors
National Research Council of Thailand
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
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) 1. Singleton pregnant women age ≥ 18 years 2. Pregnant women attending the antenatal care and intending to deliver at one of the study hospitals with gestational age \< 16 weeks 3. Thai nationality with ability to use Thai language proficiently both in spoken and written language. 4. Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions 1. Chronic hypertension prior to pregnancy 2. Hypertension during pregnancy before 20 weeks gestation. 3. Pre-eclampsia/gestational hypertension during recent pregnancy 4. Obesity defined by pre-pregnancy body mass index (BMI) ≥ 27.5 kg/m2 5. History of diabetes mellitus or gestational diabetes 6. Having gestational diabetes or overt diabetes 5. 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 ). 6. Sign written informed consent
Exclusion criteria
1. Subjects' unwillingness to participate in the study at any time of the study. 2. 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. 3. 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. 4. Subject with known obstructive sleep apnea and currently on CPAP treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of blood pressure | During 24-28 weeks gestation | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pregnancy induced hypertension (composite outcome1) | During pregnancy until delivery | Incidence of hypertensive disorder of pregnancy |
| Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2) | During pregnancy until delivery | Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section |
| Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3) | During pregnancy until delivery | Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death |
| Fasting plasma glucose | during 24-28 weeks gestation | Fasting plasma glucose (mg/dL) |
| Oral glucose tolerance test (OGTT) | during 24-28 weeks gestation | Oral Glucose Tolerance Test (OGTT) (mg/dL) |
| 24-hour ambulatory blood pressure monitoring | measured twice during 24-28 week gestation, and 32-34 week gestation | Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg) |
| Neonatal birthweight | at delivery | Neonatal birthweight (grams) |
| APGAR score | 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. |
| Neonatal length of stay in hospital | Through study completion up to 24 weeks | Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital |
| Neonatal ICU admission rate | Through study completion up to 24 weeks | Neonatal ICU admission rate (%) after birth |
| Fetal ultrasound results | During 24-28 weeks gestation | Fetal growth (grams) |
Countries
Thailand
Outcome results
None listed