The Impact of a Neonatal Sleep Intervention on Postpartum Blood Pressure in Women With Hypertensive Disorders of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Mean Arterial Pressure
研究概览
简要总结
The investigators are conducting a single center, randomized controlled trial testing the impact of a neonatal sleep intervention, the SNOO, on reducing maternal blood pressure (BP) in the postpartum period in women with hypertensive disorders of pregnancy. The SNOO is a responsive bassinet designed to automatically calm and consolidate infants by responding to their cries. Use of the SNOO has been demonstrated to improve infant sleep by 1-2 hours nightly, thus increasing maternal sleep time. The investigators plan for 110 women with pregnancies complicated by gestational hypertension or pre-eclampsia to be randomized 1:1 to either receive and use the SNOO responsive bassinet for their infants, or to receive the usual care of safe sleep education. Women will be followed longitudinally through 6 months postpartum with serial BPs, weights, mood assessments, and subjective and objective sleep assessments. The investigators hypothesize that for women with pregnancies complicated by gestational hypertension or preeclampsia, that poor maternal sleep quality contributes to increased BP in the postpartum period. The investigators further propose that compared to usual care (safe sleep education), an intervention targeted to improve neonatal sleep (the SNOO), and thus maternal sleep, will improve postpartum BP for these women.
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
- 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
- 否
入选标准
- •≥18 years old
- •Have a singleton, full-term (37 or greater weeks of gestation), live birth of a non-anomalous fetus
- •Diagnosis of gestational hypertension or pre-eclampsia by American College of Obstetricians and Gynecologists criteria
- •Enrolled in the institution's postpartum blood pressure remote monitoring program
- •Willing to undergo randomization
- •Willing to use the SNOO for their neonate in the postpartum period if randomized to that study arm
排除标准
- •<18 years old
- •Non-English speaking
- •Diagnosis of chronic hypertension
- •Diagnosis of pre-gestational diabetes
- •Diagnosis of cardiac disease
- •Diagnosis of kidney disease
- •Diagnosis of liver disease
- •Infant admitted to the neonatal intensive care unit
- •Intend to use the SNOO prior to study enrollment
- •Not willing to be randomized
- •Not willing to use the SNOO if randomized to that study arm
结局指标
主要结局
Mean Arterial Pressure
时间窗: 6 weeks postpartum
Mean arterial pressure will be calculated from the systolic and diastolic blood pressures \[(2 \* diastolic blood pressure + systolic blood pressure) / 3\] assessed using a study-provided blood pressure cuff at the time of the study follow-up visit.
次要结局
- Number of Participants on Antihypertensive Medication(s)(4 months postpartum)
- Systolic Blood Pressure(4 months postpartum)
- Body Mass Index in kg/m^2(4 months postpartum)
- Body Mass Index(6 weeks postpartum)
- Maternal Weight in Kilograms(4 months postpartum)
- Epworth Sleepiness Scale Score(6 weeks postpartum)
- Edinburgh Postnatal Depression Scale Score(6 weeks postpartum)
- Mean Arterial Pressure(4 months postpartum)
- PROMIS Sleep Disturbance Questionnaire(6 weeks postpartum)
- Median Maternal Total Daily Sleep(4 months postpartum)
- Median Maternal Daily Longest Sleep Duration(4 months postpartum)
- Diastolic Blood Pressure(4 months postpartum)
- Number of Participants With Stage 1+ Hypertension or on Antihypertensive Medication(s)(4 months postpartum)
- Breslau 7-Item Screen for Post-traumatic Stress Disorder Score(6 weeks postpartum)
- Pittsburgh Sleep Quality Index Score(6 weeks postpartum)
- Perceived Stress Scale 4 Score(6 weeks postpartum)
- Median Infant Total Daily Sleep(4 months postpartum)
- Generalized Anxiety Disorder 2-item Score(6 weeks postpartum)
- Median Infant Daily Longest Sleep Duration(4 months postpartum)
研究者
Alisse Hauspurg
Assistant Professor
University of Pittsburgh