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

NCT ID: NCT03356106

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-16
• Study Completion Date: 2019-12-31

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.

Conditions

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

Keywords

Obstructive sleep apnea; Pre-Eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP

Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery

Group Type: EXPERIMENTAL

Continuous positive airway pressure (CPAP)

Intervention Type: 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

Control

Usual antenatal care for high risk pregnancy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous 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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Research Council of Thailand

OTHER_GOV

Sponsor Role: collaborator

Ramathibodi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Visasiri Tantrakul

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Visasiri Tantrakul, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand

Locations

Phramongkutklao Hospital

Bangkok, , Thailand

Rajavithi Hospital

Bangkok, , Thailand

Ramathibodi hospital

Bangkok, , Thailand

Countries

Thailand

References

Tantrakul V, Ingsathit A, Liamsombut S, Rattanasiri S, Kittivoravitkul P, Imsom-Somboon N, Lertpongpiroon S, Jantarasaengaram S, Somchit W, Suwansathit W, Pengjam J, Siriyotha S, Panburana P, Guilleminault C, Preutthipan A, Attia J, Thakkinstian A. Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial. Respir Res. 2023 Jun 27;24(1):171. doi: 10.1186/s12931-023-02445-y.

Reference Type: DERIVED

PMID: 37370135 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ID11-58-12

Identifier Type: -

Identifier Source: org_study_id