Sleep Apnea and Fetal Growth Restriction
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Birth Weight
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 50
- •Fetal growth restriction (defined as fetal weight <10th percentile based on at least one routine 2nd trimester ultrasound without a subsequent increase to >15th percentile on any ultrasounds prior to enrollment)
- •Lower limit of gestational age at enrollment 22+0 weeks.
- •Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2 and if appropriate to be randomized and receive intervention by no later than 32+0 weeks.
- •The absence of 2 minor or 1 major markers of aneuploidy.
排除标准
- •Other known cause of fetal growth restriction (including congenital anomalies, intrauterine infection, or multiple gestation)
- •Reversed end-diastolic flow in the umbilical artery
- •Preexisting diagnosis of OSA being treated with aPAP
- •Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)
- •Hemoglobinopathies (sickle cell anemia, thalassemia)
- •Maternal craniofacial anomalies
- •Premature rupture of membranes
结局指标
主要结局
Birth Weight
时间窗: 1 day
Weight of child at time of birth
次要结局
- Gestational Age at Delivery(1 day)
研究者
Alexander M. Hincker
Assistant Professor, Department of Anesthesiology
Washington University School of Medicine