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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Interventions: Device: Continuous positive airway pressure (CPAP)

• Registration Number: NCT03356106
• Lead Sponsor: Ramathibodi Hospital

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.

Study Timeline

• Study Start: 2016-11-16
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-29
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	Continuous positive airway pressure (CPAP)	Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery

Primary Outcome Measures

Name	Time	Method
Measurement of blood pressure	During 18-20 weeks gestation	Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)

Secondary Outcome Measures

Name	Time	Method
Neonatal ICU admission rate	Through study completion up to 24 weeks	Neonatal ICU admission rate (%) after birth
24-hour ambulatory blood pressure monitoring	measured twice during 32-34 week gestation	Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
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 32-34 weeks gestation	Fasting plasma glucose (mg/dL)
Oral glucose tolerance test (OGTT)	during 24-28 weeks gestation	Oral Glucose Tolerance Test (OGTT) (mg/dL)
Incidence of pregnancy induced hypertension (composite outcome1)	During pregnancy until delivery	Incidence of hypertensive disorder of pregnancy
Fetal ultrasound results	During 32-34 weeks gestation	Uterine Doppler arterial blood flow
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 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.

Trial Locations

Locations (3)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodi hospital; 🇹🇭 Bangkok, Thailand

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand