Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04084990
Status:
TERMINATED
Last Update Posted:
2022-03-09
First Post:
2019-09-07
Brief Title:
Sleep Apnea and Fetal Growth Restriction
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Sleep Apnea and Fetal Growth Restriction
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to insufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFER
Brief Summary:
This study aims to evaluate the association between obstructive sleep apnea OSA and fetal growth restriction FGR and to assess the role of auto-titrated positive airway pressure aPAP as antenatal therapy in these patients Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor Of those patients diagnosed with OSA half will be assigned to use aPAP each night when sleeping and half will not standard care
Detailed Description:
Fetal growth restriction FGR affects 5-10 of pregnancies and is one of the leading causes of perinatal morbidity and mortality
Obstructive sleep apnea OSA is a common disorder in which a persons breathing pauses or becomes shallow during sleep These periods of low oxygen lead stress and inflammation which that may be harmful to both the mother and her fetus OSA in pregnancy has been associated with poor maternal-fetal outcomes including low birth weight preterm delivery FGR gestational hypertensionpreeclampsia gestational diabetes and higher rates of neonatal ICU admission
Auto-titrated positive airway pressure aPAP is a machine that gently delivers pressurized air via a mask to keep a patients airways free of obstruction during sleep It is currently unclear whether treatment of OSA during pregnancy in women with known FGR can improve fetal and neonatal outcomes
Obstructive sleep apnea OSA is a common disorder in which a persons breathing pauses or becomes shallow during sleep These periods of low oxygen lead stress and inflammation which that may be harmful to both the mother and her fetus OSA in pregnancy has been associated with poor maternal-fetal outcomes including low birth weight preterm delivery FGR gestational hypertensionpreeclampsia gestational diabetes and higher rates of neonatal ICU admission
Auto-titrated positive airway pressure aPAP is a machine that gently delivers pressurized air via a mask to keep a patients airways free of obstruction during sleep It is currently unclear whether treatment of OSA during pregnancy in women with known FGR can improve fetal and neonatal outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None