Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- Rate of receipt of postpartum care within 2 weeks of delivery
研究概览
简要总结
The primary objective of this research is to conduct a randomized clinical trial to examine the impact of doula-coordinated, midwife-delivered postpartum care (intervention arm) on postpartum health care utilization, health outcomes, and patient-reported experiences compared with standard postpartum care (control arm) among individuals with preterm births <34 weeks' gestation requiring neonatal intensive care unit (NICU) admission.
详细描述
This study will employ a randomized controlled trial design. Participants will be recruited from Prisma Health Richland Hospital and may be enrolled during late pregnancy (including individuals on bed rest), in a postpartum unit, or while their infant is admitted to the NICU. Inclusion criteria will be English speaking individuals ≥18 years old on Medicaid insurance, who delivered a baby <34 weeks' gestation, and whose baby will be admitted to the NICU. The control arm of the trial will receive standard postpartum care, while the intervention arm will receive nurse-midwife postpartum care and doula-coordinated postpartum care, mental health screening and referral, and screening and treatment for iron deficiency anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age above 18 at time of delivery of infant
- •English-speaking
- •Medicaid insurance coverage at the time of delivery, either as primary or secondary coverage
- •Delivery before 34 weeks' gestation
- •Infant admitted to the NICU, 10 days old or less
排除标准
- •Stillbirth
- •Infant death in the delivery room
- •Infant with severe congenital anomalies expected to result in death shortly after birth
- •Inability to provide informed consent
- •Inability to visit the infant in the NICU at least once per week
- •More than 10 days postpartum
结局指标
主要结局
Rate of receipt of postpartum care within 2 weeks of delivery
时间窗: From delivery of infant(s) to 2 weeks postpartum
Rate of receipt of postpartum care within 6 weeks of delivery
时间窗: From delivery of infant(s) to 6 weeks postpartum
次要结局
- Time to receipt of postpartum care visit within 6 weeks postpartum(From delivery of infant(s) to 6 weeks postpartum)
- Number of outpatient visits within 6 months postpartum(From delivery of infant(s) to 6 months postpartum)
- Rate of postpartum readmissions within 12 months postpartum(At 1 year postpartum)
- Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days(7, 14, 28 days)
- Rate of postpartum depression at 6 months postpartum(At 6 months postpartum)
- Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum(At 6 months postpartum)
- Rate of milk expression/breastfeeding initiation(At 6 months postpartum)
- Duration of exclusive breastfeeding(At 6 months postpartum)
- Rate of treatment for iron deficiency anemia in the intervention group(From delivery of infant(s) up to 6 weeks postpartum)
- Rate of emergency department visits within 12 months postpartum(At 1 year postpartum)
研究者
Nansi Boghossian
Associate Professor
University of South Carolina