Status:
COMPLETED
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
Lead Sponsor:
Ramathibodi Hospital
Collaborating Sponsors:
National Research Council of Thailand
Conditions:
Sleep Apnea, Obstructive
Pre-Eclampsia
Eligibility:
FEMALE
18-50 years
Phase:
NA
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...
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). Repe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT03356106
Start Date
November 16 2016
End Date
December 31 2019
Last Update
December 7 2021
Active Locations (3)
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1
Phramongkutklao Hospital
Bangkok, Thailand, 10400
2
Rajavithi Hospital
Bangkok, Thailand, 10400
3
Ramathibodi hospital
Bangkok, Thailand, 10400