NCT04783480已完成不适用
Can Birthly, an Online Childbirth Education Platform, Reduce Pregnancy-related Anxiety Compared to Usual Care: An RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in PrAS score
研究概览
简要总结
A pilot randomized, controlled trial comparing Birthly, (an online platform for live group prenatal classes taught by childbirth educators, nurses, and lactation consultants) plus standard prenatal care versus standard prenatal care alone among women with high risk pregnancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Women over 18
- •Willing and stable to give consent
- •English-speaking
- •Have access to high-speed internet available on a computer or mobile device
- •Nulliparous women have a confirmed single, live intrauterine gestation and are <20 weeks gestational age at their prenatal visit
- •Women without indications for a scheduled cesarean delivery at the time of their index prenatal visit
- •Women who have a high-risk pregnancy, as defined by all maternal conditions including hypertension, diabetes, auto-immune disorders, seizure disorder, substance use, etc
- •Agree to participation in Birthly
- •Obtaining prenatal care in the University of Pennsylvania Health System
排除标准
- •Women who do not speak at least conversational English
- •Women without internet access
- •Multiparous women
- •Women receiving group prenatal care
结局指标
主要结局
Change in PrAS score
时间窗: time of enrollment to 34-40 weeks gestation
To determine if access to an online comprehensive platform for prenatal education and childbirth courses decreases pregnancy anxiety as measured by the Pregnancy-Related Anxiety Scale (PrAS) in nulliparous women with high risk pregnancies compared to usual prenatal care. The primary study endpoint will be a 15% reduction in PrAS score from 64 to 55 with a SD of 15.22.
次要结局
- Mode of delivery(delivery)
- Difference in APGAR scores(Time of birth)
- Difference in breastfeeding rates postpartum(4-6 weeks postpartum)
- Difference in intention to breastfeed(at 34 to 40 weeks gestational age)
- Difference in breastfeeding rates at discharge after delivery(time of discharge from hospital after delivery)
- Difference in contraceptive uptake at discharge from hospital(at time of discharge from hospital after delivery, on average 1-3 days postpartum)
- Difference in contraceptive uptake postpartum(4-6 weeks postpartum)
- Number of participants with maternal readmission(delivery through 4-6 weeks postpartum)
- Difference in healthcare utilization(time of enrollment through 6-week postpartum)
- Difference in Edinburgh Postnatal Depression Scale(one-time score at 4-6 weeks postpartum)
- Number of participants who have Preterm birth(Time of delivery)
- Number of infants with a need for neonatal respiratory support outside the delivery room(Time of birth)
- Number of participants with hypertensive disorders of pregnancy(delivery through 4-6 weeks postpartum)
- Number of infants with a NICU admission(Time of birth)
研究者
研究点 (2)
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