Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies (SUSTAIN): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Rate of initial LARC utilization
研究概览
简要总结
The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.
详细描述
This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum.
The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.
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
- 13 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 13-50 years old
- •High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications
排除标准
- •Planned cesarean hysterectomy
- •Unable to provide informed consent in either English or Spanish
- •Unable to provide reliable cell phone access for the study duration
- •Not willing to provide follow-up for two years
结局指标
主要结局
Rate of initial LARC utilization
时间窗: 12 weeks postpartum (12 weeks)
Number of subjects who elect to have LARC procedure between the 2 arms
次要结局
- rates of short interval pregnancy(24 months)
- Number of patients who keep the LARC after placement(24 months)
研究者
Emma Jean Qureshey
Clinical MFM Fellow
The University of Texas Health Science Center, Houston