NCT04084990

Sleep Apnea and Fetal Growth Restriction

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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 person's 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 hypertension/preeclampsia, 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 patient's 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.

Conditions

• Obstructive Sleep Apnea
• Fetal Growth Restriction
• Pregnancy Related

Interventions

Type	Name	Description
DEVICE	S9 VPAP Adapt	Auto-titrated positive airway pressure

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-07-27
• Completion: 2021-07-27
• First posted: 2019-09-11
• Last updated: 2022-03-09
• Results posted: 2022-03-09

Locations

3 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study