Effect of the Uriclarity Program on the Perception of Insufficient Milk Supply in Postpartum Women From Three Hospitals in Piura-Peru Evaluated Through a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Reduction in Perceived Insufficient Milk Supply (PIM) Score
研究概览
简要总结
The goal of this clinical trial is to assess whether the Uriclarity Program is effective in reducing the perception of insufficient milk supply (PIM) in postpartum women. The study also aims to evaluate the feasibility of implementing this program as a lactation support strategy. The main research questions are:
Does the Uriclarity Program reduce the perception of insufficient milk supply among postpartum women? How does the program impact breastfeeding confidence and adherence to exclusive breastfeeding? Researchers will compare the Uriclarity Program to standard postpartum lactation counseling to determine its effectiveness.
Participants will:
Receive either the Uriclarity Program intervention or standard lactation counseling within 24-48 hours postpartum.
Be evaluated on days 1, 3, 7, and 14 postpartum using the PIM questionnaire to assess changes in perception.
Engage in follow-up via WhatsApp support groups (for the intervention group). This randomized controlled trial will provide evidence on whether the Uriclarity Program can effectively reduce maternal concerns about milk supply and support exclusive breastfeeding.
详细描述
This study is a randomized controlled trial (RCT) designed to evaluate the effect of the Uriclarity Program on the perception of insufficient milk supply (PIM) in postpartum women. The trial will be conducted in three hospitals in Piura, Peru between March and April 2025.
Study Rationale Perceived insufficient milk supply is a leading cause of early breastfeeding cessation, despite adequate milk production in most cases. The Uriclarity Program is a structured intervention aimed at enhancing maternal confidence in lactation by providing hands-on training and self-monitoring tools. This includes the Uriescala Ashiyama, a validated method that assesses neonatal urine color to help mothers monitor milk transfer.
Study Design Population: Postpartum women with term infants (37-41 weeks gestation) practicing exclusive breastfeeding.
Intervention Group: Receives the Uriclarity Program, consisting of a 2-hour hands-on training session, followed by WhatsApp-based follow-up support.
Control Group: Receives standard lactation counseling before hospital discharge.
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
- Single (Outcomes Assessor)
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
- •Postpartum women within 24-48 hours after delivery (vaginal or cesarean).
- •Term neonates (37-41 weeks of gestation).
- •Exclusive breastfeeding at enrollment.
- •Maternal education level of at least primary school completed.
- •Ability to use a smartphone with WhatsApp for follow-up support.
排除标准
- •Maternal conditions that may affect breastfeeding, such as flat or inverted nipples, diabetes, hypertension, or morbid obesity.
- •Maternal medication with effects on lactation.
- •Cigarette smoking.
- •Neonatal conditions impacting breastfeeding, including congenital heart defects, cleft lip/palate, or ankyloglossia.
- •Use of infant formula, pacifiers, or bottles before enrollment.
- •Diagnosed maternal or neonatal illness after study enrollment that may interfere with breastfeeding.
- •Newborns who experienced hypoglycemia, weight loss equal to or greater than 7%, or any condition related to breastfeeding failure during their hospital stay.
结局指标
主要结局
Reduction in Perceived Insufficient Milk Supply (PIM) Score
时间窗: Baseline (Day 1), Day 3, Day 7, and Day 14 postpartum
The Perceived Insufficient Milk Supply (PIM) Score will be assessed using a validated questionnaire at baseline (Day 1) and follow-ups on Days 3, 7, and 14 postpartum. A decrease in the PIM score indicates an improvement in maternal confidence regarding milk supply. The effect of the Uriclarity Program will be compared between the intervention and control groups.
次要结局
未报告次要终点