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| Name | Class |
|---|---|
| National Research Council of Thailand | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental | Nocturnal administration of continuous positive airway pressure treatment (CPAP) until delivery |
|
| Control | No Intervention | Usual antenatal care for high risk pregnancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 24-28 weeks gestation |
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 32-34 weeks gestation |
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups (mmHg) | During 24-28 weeks gestation |
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups(mmHg) | During 32-34 weeks gestation |
| Measurement of blood pressure | Difference of daytime mean blood pressure between 2 groups (mmHg) | During 18-20 weeks gestation |
| Measurement of blood pressure | Difference of daytime systolic and diastolic blood pressure between 2 groups (mmHg) | During 18-20 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour ambulatory blood pressure monitoring | 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 |
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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
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:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Visasiri Tantrakul, MD | Ramathibodi Hospital Sleep Disorder Center, Pulmonary and Care division, Department of Medicine, Ramatibodi Hospital, Mahidol University, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand | |||
| Rajavithi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37370135 | Derived | Tantrakul V, Ingsathit A, Liamsombut S, Rattanasiri S, Kittivoravitkul P, Imsom-Somboon N, Lertpongpiroon S, Jantarasaengaram S, Somchit W, Suwansathit W, Pengjam J, Siriyotha S, Panburana P, Guilleminault C, Preutthipan A, Attia J, Thakkinstian A. Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial. Respir Res. 2023 Jun 27;24(1):171. doi: 10.1186/s12931-023-02445-y. |
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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
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 9, 2021 | |
| Reset | Mar 3, 2022 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2020 | Dec 6, 2021 | Prot_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 9, 2021 | Mar 3, 2022 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D011225 | Pre-Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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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) | 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) | 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) | Incidence of preterm labor or fetal growth restriction or severe pre-eclampsia or eclampsia or death | During pregnancy until delivery |
| Fasting plasma glucose | Fasting plasma glucose (mg/dL) | during 24-28 weeks gestation |
| Fasting plasma glucose | Fasting plasma glucose (mg/dL) | during 32-34 weeks gestation |
| Oral glucose tolerance test (OGTT) | Oral Glucose Tolerance Test (OGTT) (mg/dL) | during 24-28 weeks gestation |
| Fetal ultrasound results | Fetal growth (grams) | During 24-28 weeks gestation |
| Fetal ultrasound results | Fetal growth (grams) | During 32-34 weeks gestation |
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 18-20 weeks gestation |
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 24-28 weeks gestation |
| Fetal ultrasound results | Uterine Doppler arterial blood flow | During 32-34 weeks gestation |
| Neonatal birthweight | Neonatal birthweight (grams) | 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. | 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 | Through study completion up to 24 weeks |
| Neonatal ICU admission rate | Neonatal ICU admission rate (%) after birth | Through study completion up to 24 weeks |
| Bangkok |
| 10400 |
| Thailand |
| Ramathibodi hospital | Bangkok | 10400 | Thailand |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012138 |
| Respiratory Therapy |