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Completed

NCT Number: NCT03356106

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Phramongkutklao Hospital, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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)

  3. Measurement of blood pressure

    Time frame: During 24-28 weeks gestation

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

  4. Measurement of blood pressure

    Time frame: During 32-34 weeks gestation

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

  5. Measurement of blood pressure

    Time frame: During 18-20 weeks gestation

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

  6. Measurement of blood pressure

    Time frame: During 18-20 weeks gestation

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

Secondary outcomes

  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 (composite outcome1)

    Time frame: During pregnancy until delivery

    Incidence of hypertensive disorder of pregnancy

  4. Incidence of hypertensive disorder of pregnancy 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 preterm labor or fetal growth restriction or emergency Cesarean section

  5. Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or 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. Fasting plasma glucose

    Time frame: during 24-28 weeks gestation

    Fasting plasma glucose (mg/dL)

  7. Fasting plasma glucose

    Time frame: during 32-34 weeks gestation

    Fasting plasma glucose (mg/dL)

  8. Oral glucose tolerance test (OGTT)

    Time frame: during 24-28 weeks gestation

    Oral Glucose Tolerance Test (OGTT) (mg/dL)

  9. Fetal ultrasound results

    Time frame: During 24-28 weeks gestation

    Fetal growth (grams)

  10. Fetal ultrasound results

    Time frame: During 32-34 weeks gestation

    Fetal growth (grams)

  11. Fetal ultrasound results

    Time frame: During 18-20 weeks gestation

    Uterine Doppler arterial blood flow

  12. Fetal ultrasound results

    Time frame: During 24-28 weeks gestation

    Uterine Doppler arterial blood flow

  13. Fetal ultrasound results

    Time frame: During 32-34 weeks gestation

    Uterine Doppler arterial blood flow

  14. Neonatal birthweight

    Time frame: at delivery

    Neonatal birthweight (grams)

  15. 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.

  16. 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

  17. Neonatal ICU admission rate

    Time frame: Through study completion up to 24 weeks

    Neonatal ICU admission rate (%) after birth

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2017
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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