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

December 6, 2021 updated by: Visasiri Tantrakul, Ramathibodi Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
340

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of blood pressure
Time Frame: During 24-28 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
During 24-28 weeks gestation
Measurement of blood pressure
Time Frame: During 32-34 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
During 32-34 weeks gestation
Measurement of blood pressure
Time Frame: During 24-28 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
During 24-28 weeks gestation
Measurement of blood pressure
Time Frame: During 32-34 weeks gestation
Difference of daytime mean blood pressure between 2 groups(mmHg)
During 32-34 weeks gestation
Measurement of blood pressure
Time Frame: During 18-20 weeks gestation
Difference of daytime mean blood pressure between 2 groups (mmHg)
During 18-20 weeks gestation
Measurement of blood pressure
Time Frame: During 18-20 weeks gestation
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
During 18-20 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
measured twice during 24-28 week gestation, and 32-34 week gestation
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)
measured twice during 32-34 week gestation
Incidence of pregnancy induced hypertension (composite outcome1)
Time Frame: During pregnancy until delivery
Incidence of hypertensive disorder of pregnancy
During pregnancy until delivery
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
During pregnancy until delivery
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
During pregnancy until delivery
Fasting plasma glucose
Time Frame: during 24-28 weeks gestation
Fasting plasma glucose (mg/dL)
during 24-28 weeks gestation
Fasting plasma glucose
Time Frame: during 32-34 weeks gestation
Fasting plasma glucose (mg/dL)
during 32-34 weeks gestation
Oral glucose tolerance test (OGTT)
Time Frame: during 24-28 weeks gestation
Oral Glucose Tolerance Test (OGTT) (mg/dL)
during 24-28 weeks gestation
Fetal ultrasound results
Time Frame: During 24-28 weeks gestation
Fetal growth (grams)
During 24-28 weeks gestation
Fetal ultrasound results
Time Frame: During 32-34 weeks gestation
Fetal growth (grams)
During 32-34 weeks gestation
Fetal ultrasound results
Time Frame: During 18-20 weeks gestation
Uterine Doppler arterial blood flow
During 18-20 weeks gestation
Fetal ultrasound results
Time Frame: During 24-28 weeks gestation
Uterine Doppler arterial blood flow
During 24-28 weeks gestation
Fetal ultrasound results
Time Frame: During 32-34 weeks gestation
Uterine Doppler arterial blood flow
During 32-34 weeks gestation
Neonatal birthweight
Time Frame: at delivery
Neonatal birthweight (grams)
at delivery
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.
at 1 minute and 5 minutes after birth
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
Through study completion up to 24 weeks
Neonatal ICU admission rate
Time Frame: Through study completion up to 24 weeks
Neonatal ICU admission rate (%) after birth
Through study completion up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ramathibodi Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Research Council of Thailand
The Development Potentials of Thai People Project, Ramathibodi hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Visasiri Tantrakul, MD, Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID11-58-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Apnea, Obstructive

Clinical Trials on Continuous positive airway pressure (CPAP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings