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

NCT03356106 | Completed DMC

• 1 other identifier: ID11-58-12
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Obstructive sleep apnea; Pre-Eclampsia

Outcome Measures

Primary Outcomes (6)

• Measurement of blood pressure

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

  During 24-28 weeks gestation

• Measurement of blood pressure

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

  During 32-34 weeks gestation

• Measurement of blood pressure

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

  During 24-28 weeks gestation

• Measurement of blood pressure

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

  During 32-34 weeks gestation

• Measurement of blood pressure

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

  During 18-20 weeks gestation

• Measurement of blood pressure

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

  During 18-20 weeks gestation

Secondary Outcomes (17)

• 24-hour ambulatory blood pressure monitoring

  measured twice during 24-28 week gestation, and 32-34 week gestation

• 24-hour ambulatory blood pressure monitoring

  measured twice during 32-34 week gestation

• Incidence of pregnancy induced hypertension (composite outcome1)

  During pregnancy until delivery

• 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 preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)

  During pregnancy until delivery

Study Arms (2)

CPAP

EXPERIMENTAL

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

Device: Continuous positive airway pressure (CPAP)

Control

NO INTERVENTION

Usual antenatal care for high risk pregnancy

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

CPAP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead
• National Research Council of Thailand: collaborator

Study Sites (3)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Ramathibodi hospital

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 37370135 DERIVED

MeSH Terms

Conditions

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

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Visasiri Tantrakul, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: November 29, 2017
• Study Start: November 16, 2016
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 7, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (3)