An interventional study of Continuous positive airway pressure (CPAP) in Sleep Apnea, Obstructive, Pre-Eclampsia and Hypertension, Pregnancy-Induced, sponsored by Ramathibodi Hospital. Completed at 3 sites in Thailand. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Ramathibodi Hospital · Not applicable, Interventional, and Treatment
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Among 15 studies in Sleep Apnea, Obstructive with a site in Thailand — 4 open to participants now, 4 under way, none of them phase 3. Sleep Apnea, Obstructive · Thailand.
Among the 15 studies in Sleep Apnea, Obstructive with a site in Thailand, this one has the largest enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2016, is one of 10 with no phase, and was the 4th registered.
2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
Browse Sleep Apnea, Obstructive studies →4 of the 15 studies in Sleep Apnea, Obstructive with a site in Thailand are open now. Recruiting first, the newest first:
Thammasat University · Sites in Thailand
Ages 18+
Thammasat University Hospital · Sites in Thailand
Ages 18+
Chulalongkorn University · Sites in Thailand
Ages 18–65
Ramathibodi Hospital · Sites in Thailand
Ages 19+
A study can be open while its sites in Thailand have not opened yet or have stopped. Only those recruiting at a site in Thailand →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2016.
This study's enrollment of 340 is above the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 36 across the 12 interventional studies, 150 across the 3 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 15 has an industry lead sponsor. The 6 most frequent:
Ramathibodi Hospital is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Ramathibodi Hospital has 3 studies filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Sleep Apnea, Obstructive with a site in Thailand, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Have been diagnosed as high-risk pregnancy by Obstetricians by having any of the following conditions
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery
Device: Continuous positive airway pressure (CPAP)
Usual antenatal care for high risk pregnancy
A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: During 24-28 weeks gestation
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: During 32-34 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time frame: During 24-28 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups(mmHg)
Time frame: During 32-34 weeks gestation
Measurement of blood pressure
Difference of daytime mean blood pressure between 2 groups (mmHg)
Time frame: During 18-20 weeks gestation
Measurement of blood pressure
Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg)
Time frame: During 18-20 weeks gestation
24-hour ambulatory blood pressure monitoring
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
24-hour ambulatory blood pressure monitoring
Using non-invasive technique from pulse transit time (SomnoTouch NIBP) (mmHg)
Time frame: measured twice during 32-34 week gestation
Incidence of pregnancy induced hypertension (composite outcome1)
Incidence of hypertensive disorder of pregnancy
Time frame: During pregnancy until delivery
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
Time frame: During pregnancy until delivery
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
Time frame: During pregnancy until delivery
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Time frame: during 24-28 weeks gestation
Fasting plasma glucose
Fasting plasma glucose (mg/dL)
Time frame: during 32-34 weeks gestation
Oral glucose tolerance test (OGTT)
Oral Glucose Tolerance Test (OGTT) (mg/dL)
Time frame: during 24-28 weeks gestation
Fetal ultrasound results
Fetal growth (grams)
Time frame: During 24-28 weeks gestation
Fetal ultrasound results
Fetal growth (grams)
Time frame: During 32-34 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Time frame: During 18-20 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Time frame: During 24-28 weeks gestation
Fetal ultrasound results
Uterine Doppler arterial blood flow
Time frame: During 32-34 weeks gestation
Neonatal birthweight
Neonatal birthweight (grams)
Time frame: at delivery
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.
Time frame: at 1 minute and 5 minutes after birth
Neonatal length of stay in hospital
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
Neonatal ICU admission rate
Neonatal ICU admission rate (%) after birth
Time frame: Through study completion up to 24 weeks
Plan to share: No — 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
Ran from Nov 2016 to primary completion in Nov 2019, 36 months.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 36 months is close to that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Ramathibodi Hospital