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

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ClinicalTrials.gov Identifier: NCT03356106
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Collaborators:
National Research Council of Thailand
The Development Potentials of Thai People Project, Ramathibodi hospital
Information provided by (Responsible Party):
Visasiri Tantrakul, Ramathibodi Hospital

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Pre-Eclampsia Hypertension, Pregnancy-Induced Device: Continuous positive airway pressure (CPAP) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
Actual Study Start Date : November 16, 2016
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: CPAP
Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery
Device: 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

No Intervention: Control
Usual antenatal care for high risk pregnancy



Primary Outcome Measures :
  1. Measurement of blood pressure [ Time Frame: During 24-28 weeks gestation ]
    Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)

  2. Measurement of blood pressure [ Time Frame: During 32-34 weeks gestation ]
    Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)


Secondary Outcome Measures :
  1. 24-hour ambulatory blood pressure monitoring [ Time Frame: measured twice during 24-28 week gestation, and 32-34 week gestation ]
    Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)

  2. 24-hour ambulatory blood pressure monitoring [ Time Frame: measured twice during 32-34 week gestation ]
    Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)

  3. Incidence of pregnancy induced hypertension or gestational diabetes (composite outcome1) [ Time Frame: During pregnancy until delivery ]
    Incidence of hypertensive disorder of pregnancy or gestational diabetes

  4. Incidence of hypertensive disorder of pregnancy or gestational diabetes or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2) [ Time Frame: During pregnancy until delivery ]
    Incidence of hypertensive disorder of pregnancy or gestation diabetes or preterm labor or fetal growth restriction or emergency Cesarean section

  5. Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or death (composite outcome3) [ Time Frame: During pregnancy until delivery ]
    Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death

  6. Achieve target to blood pressure control [ Time Frame: During pregnancy until delivery ]
    Blood Pressure <140/90 mmHg

  7. Fasting plasma glucose [ Time Frame: during 24-28 weeks gestation ]
    Fasting plasma glucose (mg/dL)

  8. Fasting plasma glucose [ Time Frame: during 32-34 weeks gestation ]
    Fasting plasma glucose (mg/dL)

  9. Oral glucose tolerance test (OGTT) [ Time Frame: during 24-28 weeks gestation ]
    Oral Glucose Tolerance Test (OGTT) (mg/dL)

  10. Fetal ultrasound results [ Time Frame: During 24-28 weeks gestation ]
    Fetal growth (grams)

  11. Fetal ultrasound results [ Time Frame: During 32-34 weeks gestation ]
    Fetal growth (grams)

  12. Fetal ultrasound results [ Time Frame: During 18-20 weeks gestation ]
    Uterine Doppler arterial blood flow

  13. Fetal ultrasound results [ Time Frame: During 24-28 weeks gestation ]
    Uterine Doppler arterial blood flow

  14. Fetal ultrasound results [ Time Frame: During 32-34 weeks gestation ]
    Uterine Doppler arterial blood flow

  15. Neonatal birthweight [ Time Frame: at delivery ]
    Neonatal birthweight (grams)

  16. APGAR score [ Time Frame: at 1 minute and 5 minutes after birth ]
    The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form an acronym (Appearance, Pulse, Grimace, Activity, Respiration). Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.

  17. Neonatal length of stay in hospital [ Time Frame: Through study completion up to 24 weeks ]
    Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital

  18. Neonatal ICU admission rate [ Time Frame: Through study completion up to 24 weeks ]
    Neonatal ICU admission rate (%) after birth

  19. Placenta character [ Time Frame: at delivery ]
    placenta weight (gram)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
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
  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 ≥ 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356106


Contacts
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Contact: Visasiri Tantrakul, MD 668 91452992 vtantrakul@gmail.com
Contact: Ammarin Thakkinstian, PhD 668 2 200 1383 ammarin.tha@mahidol.ac.th

Locations
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Thailand
Phramongkutklao Hospital Not yet recruiting
Bangkok, Thailand, 10400
Contact: Prapun Kittivoravitkul, MD    (66)948951526    prapunn@hotmail.com   
Rajavithi Hospital Recruiting
Bangkok, Thailand, 10400
Contact: Surasak jantarasaengaram, MD    22003763    surasakjan@yahoo.com   
Contact: , MD         
Ramathibodi hospital Recruiting
Bangkok, Thailand, 10400
Contact: Visasiri Tantrakul, MD    22003763    vtantrakul@gmail.com   
Contact: Ammarin Thakkinstian, PhD    022001282    ammarin.tha@mahidol.ac.th   
Sponsors and Collaborators
Ramathibodi Hospital
National Research Council of Thailand
The Development Potentials of Thai People Project, Ramathibodi hospital
Investigators
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Principal Investigator: Visasiri Tantrakul, MD Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
  Study Documents (Full-Text)

Documents provided by Visasiri Tantrakul, Ramathibodi Hospital:

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Responsible Party: Visasiri Tantrakul, Dr., Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT03356106     History of Changes
Other Study ID Numbers: ID11-58-12
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Visasiri Tantrakul, Ramathibodi Hospital:
Obstructive sleep apnea
Pre-Eclampsia

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pregnancy Complications
Hypertension
Vascular Diseases
Cardiovascular Diseases