Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02303834
Status:
TERMINATED
Last Update Posted:
2018-05-03
First Post:
2014-11-25
Brief Title:
CPAP in Preeclampsia
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
Single Blinded Randomised Control Trial of Treatment of Sleep Disordered Breathing in Preeclampsia With Nasal CPAP
Status:
TERMINATED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study design
Single blinded randomised control trial
Planned sample size
30 women randomized 21 to receive either CPAP or no CPAP
Objectives
Primary objective Assess the effects of nasal CPAP on sleep physiology 24 blood pressures and fetal movements in pregnant women 24-37 weeks gestation with preeclampsia
Secondary objective Assess baseline sleep physiology blood pressure control and fetal well-being in pregnant women 24-37 weeks gestation with preeclampsia by completing sleep studies 24 hour blood pressure monitors CO2 monitors and nocturnal fetal movement and HR monitors
Study Procedure
Participants will be recruited from the antenatal ward or high-risk antenatal clinic Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night following an initial baseline overnight sleep study
Baseline- Night 1
1 Sleep study with fetal movement and HR monitor
2 24 hour BP monitor
3 CO2 monitor
Intervention- Night 2 Nasal CPAP device or no CPAP
1 Sleep study with fetal movement and HR monitor
2 24 hour BP monitor
3 CO2 monitor
Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participants personal health their childs birth details and health
Single blinded randomised control trial
Planned sample size
30 women randomized 21 to receive either CPAP or no CPAP
Objectives
Primary objective Assess the effects of nasal CPAP on sleep physiology 24 blood pressures and fetal movements in pregnant women 24-37 weeks gestation with preeclampsia
Secondary objective Assess baseline sleep physiology blood pressure control and fetal well-being in pregnant women 24-37 weeks gestation with preeclampsia by completing sleep studies 24 hour blood pressure monitors CO2 monitors and nocturnal fetal movement and HR monitors
Study Procedure
Participants will be recruited from the antenatal ward or high-risk antenatal clinic Following informed consent participants will be randomly assigned to receive either CPAP or no CPAP for one night following an initial baseline overnight sleep study
Baseline- Night 1
1 Sleep study with fetal movement and HR monitor
2 24 hour BP monitor
3 CO2 monitor
Intervention- Night 2 Nasal CPAP device or no CPAP
1 Sleep study with fetal movement and HR monitor
2 24 hour BP monitor
3 CO2 monitor
Post-partum questionnaire A brief questionnaire to be completed within the first 6 weeks post-partum related to the participants personal health their childs birth details and health
Detailed Description:
DESIGN Single blinded randomized control trial STUDY GROUPS Women diagnosed with preeclampsia by their treating physicians BP14090 and proteinuria 300mg in 24 hours who are being managed either as inpatients or out-patients They will be randomized in a 21 ratio to receive active CPAP or no CPAP either in hospital if they are inpatients or at home outpatients
NUMBER OF PARTICIPANTS A total of 30 women will be recruited NUMBER OF CENTRES This study will be conducted at 2 centres- Royal Hospital for Women Randwick and Royal Prince Alfred Hospital Camperdown The aim will be to recruit 15 participants from each site
INTERVENTIONS The intervention is nasal CPAP The intervention group will be fitted with nasal CPAP on night 2 set to deliver positive pressure airway ventilation The control group will not receive CPAP on night 2 The CPAP devices to be used are the ResMed S9 and the Philips Respironics REMstar Pro both of which are automatically setting machines that respond to the presence of snoring partial airway obstruction and complete apneas and increase airway pressure to a therapeutic level These systems are commercially available and in widespread everyday routine clinical use in Australia Nasal CPAP has been used for over 30 years including in pregnant women and has been found to be very safe therapy
DURATION Participants will be required to undertake 2 overnight sleep studiesBP monitorsCO2 monitors and complete a 10 minute questionnaire in the first 6 weeks post-partum The study will be undertaken between 1614 to 1616
INVESTIGATION PLAN Following informed consent participants will be enrolled to undergo the following investigational plan
Baseline demographic data all enrolled participants will be asked to provide the following information
age
gestation
height
current weight and pre-pregnancy weight
medical history
medications
family history
snoring history
smoking and illicit drug taking history
They will then be asked to complete a Modified Epworth Sleepiness Scale questionnaire
Overnight Sleep Study BP monitor and Fetal Monitor
Inpatients will undertake a Sleep Study with accompanying 24 BP monitor CO2 monitor and fetal movementHR monitor in their hospital bed on the day of recruitment Outpatients will be given the equipment and a brief lesson on its use by investigators on the day of recruitment and asked to perform the study in their own homes They will be asked to then return the equipment to the hospital the following day for analysis
Second Night- Intervention On the subsequent day the active group will be fitted with a nasal CPAP device and given a brief lesson on its use Intervention group- CPAP Controls- no CPAP Inpatients will then complete a Sleep study 24 hour BP monitor CO2 monitor and fetal movementsHR monitor whilst on nasal CPAP Outpatients will complete the same tests with nasal CPAP in their own homes Outpatients will then return the equipment to the hospital for analysis the following day
Sleep Study- Sonomat HST The Sonomat is a portable mat that is placed on top of the participants mattress underneath the sheets It contains a microphone and four vibration sensors to detect breath sounds breathing movements and body movement It will assess snoring the number of apneas the number of hypopneas the number of arousals and hourly blood oxygen saturation throughout the night It also measures the total number of fetal movements throughout the night and will be used to calculate average hourly fetal movements
The Sonomat HST ARTG number Sleep Assessment Device 179807 software 179908 is registered with the Therapeutic Goods Administration and is routine use to perform ambulatory sleep assessments
24 Hour BP monitor and CO2 monitor A blood pressure cuff will be applied to the left upper arm for 24 hours It will inflate hourly to measure the participants systolic and diastolic blood pressure mmHg and will record all values From this average nocturnal and daytime BPs will be calculated The device to be used is a Spacelabs portable oscillometric system ABP 20217
The CO2 monitor is a transcutaneous monitor applied to the patients earlobe which continuously measures CO2 O2 and HR From this we can monitor alterations in CO2 and O2 such as desaturations complete apnoeas and hypercapnic episodes
Nasal CPAP Continuous positive airway pressure The CPAP devices used are ResMed S9 or Philips-Respironics REMstar Pro which are automatically setting machines that respond to the presence of upper airway obstruction and complete apneas and increase airway pressure to a therapeutic level
The CPAP system is a small machine that sits at the bedside with a mask attached to the machine via a tube The mask fits comfortably over the nose and delivers a steady stream of air under slight pressure auto-set It is to be worn throughout the night whilst the participant sleeps Modern nasal CPAP masks and nasal pillow are very comfortable and provided there is a gentle background flow of air they are very easy to use and allow normal sleep
Post-partum questionnaire All participants will be asked to complete a brief questionnaire which will be sent to them via email or conventional mail in the first 6 weeks post-partum This will ask questions regarding their gestation at delivery fetal birth weight maternal and fetal health and current signssymptoms of sleep-disordered breathing
NUMBER OF PARTICIPANTS A total of 30 women will be recruited NUMBER OF CENTRES This study will be conducted at 2 centres- Royal Hospital for Women Randwick and Royal Prince Alfred Hospital Camperdown The aim will be to recruit 15 participants from each site
INTERVENTIONS The intervention is nasal CPAP The intervention group will be fitted with nasal CPAP on night 2 set to deliver positive pressure airway ventilation The control group will not receive CPAP on night 2 The CPAP devices to be used are the ResMed S9 and the Philips Respironics REMstar Pro both of which are automatically setting machines that respond to the presence of snoring partial airway obstruction and complete apneas and increase airway pressure to a therapeutic level These systems are commercially available and in widespread everyday routine clinical use in Australia Nasal CPAP has been used for over 30 years including in pregnant women and has been found to be very safe therapy
DURATION Participants will be required to undertake 2 overnight sleep studiesBP monitorsCO2 monitors and complete a 10 minute questionnaire in the first 6 weeks post-partum The study will be undertaken between 1614 to 1616
INVESTIGATION PLAN Following informed consent participants will be enrolled to undergo the following investigational plan
Baseline demographic data all enrolled participants will be asked to provide the following information
age
gestation
height
current weight and pre-pregnancy weight
medical history
medications
family history
snoring history
smoking and illicit drug taking history
They will then be asked to complete a Modified Epworth Sleepiness Scale questionnaire
Overnight Sleep Study BP monitor and Fetal Monitor
Inpatients will undertake a Sleep Study with accompanying 24 BP monitor CO2 monitor and fetal movementHR monitor in their hospital bed on the day of recruitment Outpatients will be given the equipment and a brief lesson on its use by investigators on the day of recruitment and asked to perform the study in their own homes They will be asked to then return the equipment to the hospital the following day for analysis
Second Night- Intervention On the subsequent day the active group will be fitted with a nasal CPAP device and given a brief lesson on its use Intervention group- CPAP Controls- no CPAP Inpatients will then complete a Sleep study 24 hour BP monitor CO2 monitor and fetal movementsHR monitor whilst on nasal CPAP Outpatients will complete the same tests with nasal CPAP in their own homes Outpatients will then return the equipment to the hospital for analysis the following day
Sleep Study- Sonomat HST The Sonomat is a portable mat that is placed on top of the participants mattress underneath the sheets It contains a microphone and four vibration sensors to detect breath sounds breathing movements and body movement It will assess snoring the number of apneas the number of hypopneas the number of arousals and hourly blood oxygen saturation throughout the night It also measures the total number of fetal movements throughout the night and will be used to calculate average hourly fetal movements
The Sonomat HST ARTG number Sleep Assessment Device 179807 software 179908 is registered with the Therapeutic Goods Administration and is routine use to perform ambulatory sleep assessments
24 Hour BP monitor and CO2 monitor A blood pressure cuff will be applied to the left upper arm for 24 hours It will inflate hourly to measure the participants systolic and diastolic blood pressure mmHg and will record all values From this average nocturnal and daytime BPs will be calculated The device to be used is a Spacelabs portable oscillometric system ABP 20217
The CO2 monitor is a transcutaneous monitor applied to the patients earlobe which continuously measures CO2 O2 and HR From this we can monitor alterations in CO2 and O2 such as desaturations complete apnoeas and hypercapnic episodes
Nasal CPAP Continuous positive airway pressure The CPAP devices used are ResMed S9 or Philips-Respironics REMstar Pro which are automatically setting machines that respond to the presence of upper airway obstruction and complete apneas and increase airway pressure to a therapeutic level
The CPAP system is a small machine that sits at the bedside with a mask attached to the machine via a tube The mask fits comfortably over the nose and delivers a steady stream of air under slight pressure auto-set It is to be worn throughout the night whilst the participant sleeps Modern nasal CPAP masks and nasal pillow are very comfortable and provided there is a gentle background flow of air they are very easy to use and allow normal sleep
Post-partum questionnaire All participants will be asked to complete a brief questionnaire which will be sent to them via email or conventional mail in the first 6 weeks post-partum This will ask questions regarding their gestation at delivery fetal birth weight maternal and fetal health and current signssymptoms of sleep-disordered breathing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None