Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Presence of Fetal Growth Restriction at Birth
研究概览
简要总结
Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor maternal and fetal outcomes. The investigators propose a prospective observational study to assess the utility of continuous positive airway pressure (CPAP) administration (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing as measured by ambulatory sleep monitoring applied in the hospital setting.
详细描述
Hypothesis:
CPAP application in SDB-diagnosed parturients will decrease fetal and maternal morbidity.
Specific Aims:
- To screen women after their first trimester of pregnancy that are at risk for carrying babies with fetal growth restriction (FGR) for presence of SDB (FGR is commonly diagnosed at 20 weeks gestation by ultrasound as standard of care) and to follow their diagnosis and treatment with CPAP, as per standard of care, for the remainder of their pregnancy or order to follow fetal and maternal outcomes.
a. Screen = parturients affirm presence of snoring. b. Screen positive parturients are further assessed with 1-2 nights of ambulatory sleep and respiration monitor to confirm SDB b. SDB positive parturients are offered treatment, as per standard of care, with CPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •i. Prepartum
- •18 years of age and older, able to provide informed consent
- •Diagnosis of fetal growth restriction (by ultrasound)
排除标准
- •• Patient refusal
- •Inability to provide informed consent
- •Known maternal severe cardiopulmonary disease
- •Known fetal anomalies
研究组 & 干预措施
Parturients with FGR/OSA who use CPAP
Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for Continuous Positive Airway Pressure (CPAP). Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).
干预措施: Continuous Positive Airway Pressure (CPAP) (Device)
Parturients with FGR/OSA and no CPAP
Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for CPAP. Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance).
结局指标
主要结局
Presence of Fetal Growth Restriction at Birth
时间窗: 6 months
expressed as a percentile of predicted weight
次要结局
- Change in estimated fetal weight based on crossing nomograms(6 months)