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

Ramathibodi Hospital340 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

340

Conditions

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

Interventions

Continuous positive airway pressure (CPAP)DEVICE

A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (3)

Phramongkutklao Hospital

Bangkok, Thailand

Rajavithi Hospital

Bangkok, Thailand

Ramathibodi hospital

Bangkok, Thailand

Outcomes

Primary Outcomes

Measurement of blood pressure

Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)

Time frame: During 24-28 weeks gestation

Measurement of blood pressure

Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)

Time frame: During 32-34 weeks gestation

Measurement of blood pressure

Difference of daytime mean blood pressure between 2 groups (mmHg)

Time frame: During 24-28 weeks gestation

Measurement of blood pressure

Difference of daytime mean blood pressure between 2 groups(mmHg)

Time frame: During 32-34 weeks gestation

Measurement of blood pressure

Difference of daytime mean blood pressure between 2 groups (mmHg)

Time frame: During 18-20 weeks gestation

Measurement of blood pressure

Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)

Time frame: During 18-20 weeks gestation

Secondary Outcomes

24-hour ambulatory blood pressure monitoring

Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)

Time frame: 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)

Data from ClinicalTrials.gov

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