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.

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.

Primary Outcome: Change in PIM scores at days 1, 3, 7, and 14 postpartum, assessed using a validated PIM questionnaire.

Sample Size: 40 participants per group (total 80 mothers), determined using a power analysis for proportion comparison.

Statistical Analysis Between-group comparison: Mann-Whitney U test for ordinal PIM scores. Longitudinal analysis: Mixed-effects ordinal logistic regression to evaluate PIM progression over time.

Confounder adjustment: Multivariable logistic regression, controlling for maternal age, parity, and education.

Significance This study seeks to provide high-quality evidence on a low-cost, scalable intervention that could reduce unnecessary formula supplementation and promote exclusive breastfeeding. If successful, the Uriclarity Program could be integrated into maternal care policies to support breastfeeding mothers.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

The following Individual Participant Data (IPD) will be shared:

1. De-identified participant-level data for Perceived Insufficient Milk Supply (PIM) scores at baseline (Day 1), Day 3, Day 7, and Day 14 postpartum.
2. Demographic variables (age, parity, education level).
3. Intervention group assignment (Uriclarity Program vs. Control). Data will be available upon reasonable request for research purposes only, following ethical and regulatory guidelines.

IPD and supporting documents will be available starting 6 months after the primary results are published and will remain accessible for at least 1 year.

De-identified Individual Participant Data (IPD) and supporting documents will be accessible to qualified researchers affiliated with academic institutions, research organizations, or healthcare agencies.

Researchers must submit a formal request, including a study proposal and ethical approval, to the principal investigator. Upon approval, data will be shared via a secured repository or institutional data-sharing agreement.

Data will be available for secondary analysis, systematic reviews, and meta-analyses, but not for commercial use or participant re-identification.