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临床试验/NCT04692480
NCT04692480已完成不适用

A Pilot Study Assessing the Feasibility and Effectiveness of an Antepartum Breastfeeding Educational Video on In-Hospital and 6 Month Exclusive Breastfeeding Rates

Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
Maternal perception of milk supply at hospital discharge

研究概览

简要总结

Given the known health benefits of breast milk, the World Health Organization and pediatric and obstetrical professional societies all recommend that babies only consume breast milk (also referred to as "exclusive breastfeeding (EBF)") through 6 months of age. While many women initiate breastfeeding while at the study institution hospital, the rate of exclusive breastfeeding when mothers and babies are discharged is only 34%. Sixty percent of mothers stopped breastfeeding earlier than intended to primarily due to concerns about difficulty with lactation (i.e. sore nipples, inadequate milk supply), baby's nutrition (i.e weight gain and satiety) and effort required to pump breast milk. It is known that prenatal education by trained health care providers is effective in increasing EBF rates; however, these interventions are time and labor intensive and require employment of breastfeeding specialists. Therefore, a simple, brief, easily accessible breastfeeding education tool is needed to directly educated new mothers on how to breastfeed and what the actual nutritional needs of an infant are in order to support women's breastfeeding goals. The objective of this study is to assess whether a simple breastfeeding education video viewed at the time of admission to the hospital for delivery will increase EBF at the time of hospital discharge through 6 months postpartum by improving women's perception of their milk supply and their breast feeding efficiency.

The investigators predict that woman who view a short breastfeeding education video just prior to delivery will have an improved perception of their breastfeeding efficiency and milk supply and will be more likely to avoid formula use while admitted to the hospital and though 6 months postpartum. In this study, the investigators will randomly assign women to view an educational video focused on breastfeeding in the first days of a baby's life and compare them to women who receive the standard educational pamphlet on breastfeeding given to all women delivering at the study institution. The investigators will then survey each participant after her delivery on how she is feeding her baby (breast milk, formula, or both) and how she perceives her milk supply and breastfeeding efficiency just before she is discharged from the hospital. The investigators will then call women on the phone at 6 weeks, 3 months and 6 months to reassess how they are feeding their babies (breast milk, formula or both). In addition to baseline characteristics about the individuals such as age, race, and employment status, information regarding their pregnancy and delivery will be obtained to assess for any confounding factors that may effect their ability to breastfeed. This research will help determine if video education can provide sufficient education to help increase breastfeeding rates. Additionally, this research may inform the research community on the overall effectiveness of video education in healthcare, allowing for a similar approach to be used for other educational initiatives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • nulliparous woman
  • >18 years of age
  • Fluency in English or Spanish
  • Intention to exclusively breastfeed
  • Admitted to Women and Infants Hospital (Providence, RI) for induction of labor, labor, or primary cesarean delivery.
  • Gestational age between 37'0-42'0

排除标准

  • Prior breastfeeding experience (ex: induced lactation for prior child)
  • Contraindications to breastfeeding,
  • Intention to utilize formula
  • Extremis prohibiting consent
  • Women who require Intensive Care Unit (ICU) admission, whose infants require Neonatal Intensive Care Unit (NICU) admission, or who suffer an intrapartum fetal demise or neonatal death will be excluded from final analysis.

结局指标

主要结局

Maternal perception of milk supply at hospital discharge

时间窗: 1-4 days Postpartum

Using the validated Perception of Insufficient Milk Questionnaire, a Likert scale survey ranging from 1 (strongly disagree) to 10 (strongly agree) the investigators aim to determine if maternal perception of milk supply at time of hospital discharge is increased for women who viewed the breastfeeding video compared to those who viewed the control PDF materials. Outcome will be measured on the Likert scale.

Maternal perception of breastfeeding efficiency at hospital discharge

时间窗: 1-4 days Postpartum

Using the validated Breastfeeding Self-Efficiency Scale-Short Form, a Likert scale survey ranging from 1 (not confident at all) to 5 (very confident), the investigators aim to determine if maternal perception of breastfeeding efficiency at time of hospital discharge is increased for women who viewed the breastfeeding video compared to those who viewed the control PDF materials.

Breastfeeding rates at hospital discharge

时间窗: 1-4 days Postpartum

Using a self reported survey of infant feeding practices including exclusive breastfeeding, breastfeeding with formula supplementation or formula feeding only, the investigators aim to determine if participants who viewed the breastfeeding education video had increased breastfeeding rates compared to women who viewed the control PDF materials at time of hospital discharge.

次要结局

  • Breastfeeding rates at 3 months postpartum(3 months postpartum)
  • Breastfeeding rates at 6 months postpartum(6 months postpartum)
  • Breastfeeding rates at 6 weeks postpartum(6 weeks postpartum)
  • Maternal perceptions of acceptability of breastfeeding education interventions(1-4 days Postpartum)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie Griffin

Obstetrics and Gynecology House Officer

Women and Infants Hospital of Rhode Island

研究点 (2)

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