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临床试验/NCT04135612
NCT04135612已完成不适用

The Use of Smartphone Based Communication for Encouragement of Breastfeeding and Early Detection of Post-partum Depression- A Randomized Control Trial

Wolfson Medical Center2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2019年10月30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
224
试验地点
2
主要终点
breastfeeding rates

研究概览

简要总结

We will aim to study the impact of introducing a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team (obstetricians, neonatologists, midwives, lactation consultants, nurses, and psychologist) on breastfeeding rates.

详细描述

Our study will aim to introduce a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team. This team will include: an obstetrician specialized in maternal-fetal medicine, a general obstetrician, two certified midwives, two certified lactation-consultants, a neonatologist, and a psychologist. Our vision and hypothesis for the current study- is that an intimate personalized daily communication and feedback platform between each woman and the support team will improve the rates of initiation of lactation and of full/partial lactation at various time points postpartum.

Geographic area - A university affiliated hospital in southern Tel-Aviv that serves a population of over 500,000 people. Our annual delivery volume is 5000 deliveries with a 22% CS rate. The population is heterogeneous and consists of a high rate of women with intermediate-low income as well as a population of refugees from Africa (mostly Eritrea), both populations still have a very high rate of smartphone owners based on our previous experience.

Methods- Prospective, single-center randomized controlled trial. Eligibility will be limited to women expressing wish to breastfeed, with singleton gestations, delivering > 37 weeks with no other maternal/neonatal significant morbidities.

Study design and group assignment -Women meeting inclusion criteria who own a smartphone will be approached for recruitment on postpartum day 1. After obtaining a written informed consent, patients will be randomly assigned either to the intervention group (smartphone group) or to the control group in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.

The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization. Patients allocated to the control group will receive the aforementioned care. Patients assigned to the smartphone group will receive our standard care, and in addition will have an application installed to their smartphones. This application will be in Hebrew language, simple to use, and specifically designed to the needs of the current study.

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 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women expressing wish to breastfeed, with singleton gestations, delivering > 37 weeks with no other maternal/neonatal significant morbidities.

排除标准

  • refusal to participate
  • no smartphone availability

结局指标

主要结局

breastfeeding rates

时间窗: 3 months

Full or partial breastfeeding at fixed intervals.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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