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临床试验/NCT04049032
NCT04049032已完成不适用

MUSC Women's Reproductive Behavioral Health Program for Opioid Use During Pregnancy

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Percent of infants born with Neonatal Abstinence Syndrome (NAS)

研究概览

简要总结

To compare maternal and newborn outcomes among pregnant women with OUD receiving care via telemedicine versus in-person.

详细描述

Participants: Pregnant women with OUD.

Intervention: Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine.

Design: A cohort derived from a prospectively collected database including 98 women receiving perinatal OUD treatment in an obstetric practice by telemedicine or in-person and followed until 6-8 weeks postpartum from September, 2017 to December, 2018. Logistic regression with propensity score adjustment was applied to reduce group selection bias and control for potentially confounding variables.

Setting: Four outpatient obstetric practices in the southeast.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult females, any race or ethnicity, age 18-45 years
  • Currently pregnant
  • Opioid Use Disorder (OUD)
  • received in person or telemedicine treatment for OUD in their obstetrician's office

排除标准

  • Not currently pregnant or receiving perinatal care
  • Not in agreement with Patient-Physician Agreement

结局指标

主要结局

Percent of infants born with Neonatal Abstinence Syndrome (NAS)

时间窗: At Delivery

Newborn withdrawal, also know as NAS gathered via electronic health record

Number of individuals retained in treatment

时间窗: 6-8 weeks postpartum

Uninterrupted addiction treatment during pregnancy through 6-8 weeks postpartum

次要结局

  • Positive urine drug screens(At delivery and 6-8 weeks postpartum)
  • Length of newborn hospital stay and birth weight(Assessed up to 6 months following delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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