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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive sleep apnea, Pre-Eclampsia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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
    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

Sites / Locations

  • Phramongkutklao Hospital
  • Rajavithi Hospital
  • Ramathibodi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CPAP

Control

Arm Description

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

Usual antenatal care for high risk pregnancy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

24-hour ambulatory blood pressure monitoring
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
24-hour ambulatory blood pressure monitoring
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Incidence of pregnancy induced hypertension (composite outcome1)
Incidence of hypertensive disorder of pregnancy
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Oral glucose tolerance test (OGTT)
Oral Glucose Tolerance Test (OGTT) (mg/dL)
Fetal ultrasound results
Fetal growth (grams)
Fetal ultrasound results
Fetal growth (grams)
Fetal ultrasound results
Uterine Doppler arterial blood flow
Fetal ultrasound results
Uterine Doppler arterial blood flow
Fetal ultrasound results
Uterine Doppler arterial blood flow
Neonatal birthweight
Neonatal birthweight (grams)
APGAR score
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.
Neonatal length of stay in hospital
Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital
Neonatal ICU admission rate
Neonatal ICU admission rate (%) after birth

Full Information

First Posted
September 26, 2017
Last Updated
December 6, 2021
Sponsor
Ramathibodi Hospital
Collaborators
National Research Council of Thailand, The Development Potentials of Thai People Project, Ramathibodi hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03356106
Brief Title
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy
Official Title
Screening and Treatment of Obstructive Sleep Apnea in High-risk Pregnancy: A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
Collaborators
National Research Council of Thailand, The Development Potentials of Thai People Project, Ramathibodi hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Pre-Eclampsia, Hypertension, Pregnancy-Induced
Keywords
Obstructive sleep apnea, Pre-Eclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual antenatal care for high risk pregnancy
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
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 Outcome Measure Information:
Title
Measurement of blood pressure
Description
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time Frame
During 24-28 weeks gestation
Title
Measurement of blood pressure
Description
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time Frame
During 32-34 weeks gestation
Title
Measurement of blood pressure
Description
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time Frame
During 24-28 weeks gestation
Title
Measurement of blood pressure
Description
Difference of daytime mean blood pressure between 2 groups(mmHg)
Time Frame
During 32-34 weeks gestation
Title
Measurement of blood pressure
Description
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time Frame
During 18-20 weeks gestation
Title
Measurement of blood pressure
Description
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time Frame
During 18-20 weeks gestation
Secondary Outcome Measure Information:
Title
24-hour ambulatory blood pressure monitoring
Description
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Time Frame
measured twice during 24-28 week gestation, and 32-34 week gestation
Title
24-hour ambulatory blood pressure monitoring
Description
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Time Frame
measured twice during 32-34 week gestation
Title
Incidence of pregnancy induced hypertension (composite outcome1)
Description
Incidence of hypertensive disorder of pregnancy
Time Frame
During pregnancy until delivery
Title
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section (composite outcome2)
Description
Incidence of hypertensive disorder of pregnancy or preterm labor or fetal growth restriction or emergency Cesarean section
Time Frame
During pregnancy until delivery
Title
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death (composite outcome3)
Description
Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death
Time Frame
During pregnancy until delivery
Title
Fasting plasma glucose
Description
Fasting plasma glucose (mg/dL)
Time Frame
during 24-28 weeks gestation
Title
Fasting plasma glucose
Description
Fasting plasma glucose (mg/dL)
Time Frame
during 32-34 weeks gestation
Title
Oral glucose tolerance test (OGTT)
Description
Oral Glucose Tolerance Test (OGTT) (mg/dL)
Time Frame
during 24-28 weeks gestation
Title
Fetal ultrasound results
Description
Fetal growth (grams)
Time Frame
During 24-28 weeks gestation
Title
Fetal ultrasound results
Description
Fetal growth (grams)
Time Frame
During 32-34 weeks gestation
Title
Fetal ultrasound results
Description
Uterine Doppler arterial blood flow
Time Frame
During 18-20 weeks gestation
Title
Fetal ultrasound results
Description
Uterine Doppler arterial blood flow
Time Frame
During 24-28 weeks gestation
Title
Fetal ultrasound results
Description
Uterine Doppler arterial blood flow
Time Frame
During 32-34 weeks gestation
Title
Neonatal birthweight
Description
Neonatal birthweight (grams)
Time Frame
at delivery
Title
APGAR score
Description
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.
Time Frame
at 1 minute and 5 minutes after birth
Title
Neonatal length of stay in hospital
Description
Neonatal length of hospital stay (days) after birth until the newborn is discharged from the hospital
Time Frame
Through study completion up to 24 weeks
Title
Neonatal ICU admission rate
Description
Neonatal ICU admission rate (%) after birth
Time Frame
Through study completion up to 24 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Visasiri Tantrakul, MD
Organizational Affiliation
Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Ramathibodi hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
For the first five years after the trial is concluded (upon acceptance of the primary manuscript for publication) the data will remain accessible only to the trial investigators for the purpose of additional analyses and publications. Thereafter other interested researchers may request in writing to the Steering Committee access to the data for the purpose of meta-analyses, with approval of a protocol and signed data access agreement via contacting the principle investigators of Division of Sleep Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

Learn more about this trial

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

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