Clinical trial NCT03356106: Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
Official title: Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Keywords: Obstructive sleep apnea
Pre-Eclampsia
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
name: The Development Potentials of Thai People Project, Ramathibodi hospital
First posted: 2017-11-29
Enrollment: 340
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Measurement of blood pressure
timeFrame: During 24-28 weeks gestation
measure: Measurement of blood pressure
timeFrame: During 32-34 weeks gestation
measure: Measurement of blood pressure
timeFrame: During 24-28 weeks gestation
measure: Measurement of blood pressure
timeFrame: During 32-34 weeks gestation
measure: Measurement of blood pressure
timeFrame: During 18-20 weeks gestation
measure: Measurement of blood pressure
timeFrame: During 18-20 weeks gestation
Secondary outcomes:
measure: 24-hour ambulatory blood pressure monitoring
timeFrame: measured twice during 24-28 week gestation, and 32-34 week gestation
measure: 24-hour ambulatory blood pressure monitoring
timeFrame: measured twice during 32-34 week gestation
measure: Incidence of pregnancy induced hypertension (composite outcome1)
timeFrame: During pregnancy until delivery
measure: Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)
timeFrame: During pregnancy until delivery
measure: Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)
timeFrame: During pregnancy until delivery
measure: Fasting plasma glucose
timeFrame: during 24-28 weeks gestation
measure: Fasting plasma glucose
timeFrame: during 32-34 weeks gestation
measure: Oral glucose tolerance test (OGTT)
timeFrame: during 24-28 weeks gestation
measure: Fetal ultrasound results
timeFrame: During 24-28 weeks gestation
measure: Fetal ultrasound results
timeFrame: During 32-34 weeks gestation
measure: Fetal ultrasound results
timeFrame: During 18-20 weeks gestation
measure: Fetal ultrasound results
timeFrame: During 24-28 weeks gestation
measure: Fetal ultrasound results
timeFrame: During 32-34 weeks gestation
measure: Neonatal birthweight
timeFrame: at delivery
measure: APGAR score
timeFrame: at 1 minute and 5 minutes after birth
measure: Neonatal length of stay in hospital
timeFrame: Through study completion up to 24 weeks
measure: Neonatal ICU admission rate
timeFrame: Through study completion up to 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi hospital
Study officials:
affiliation: Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
name: Visasiri Tantrakul, MD
role: PRINCIPAL_INVESTIGATOR
References: