Effect of the Uriclarity Program on Perceived Milk Supply in Postpartum Women in Piura-Peru

NCT06857461 | Completed

• 1 other identifier: 202500001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Perceived Insufficient Milk Supply

Keywords

Breastfeeding; Uriclarity Program; Perceived Insufficient Milk Supply; Lactation Support

Outcome Measures

Primary Outcomes (1)

• Reduction in Perceived Insufficient Milk Supply (PIM) Score

  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.

  Baseline (Day 1), Day 3, Day 7, and Day 14 postpartum

Study Arms (2)

Uriclarity Program Group

EXPERIMENTAL

Participants in this arm will receive the Uriclarity Program, a structured lactation support intervention. The program includes a two-hour in-person workshop within the first 24-48 hours postpartum, covering breastfeeding education, self-monitoring using the Ashiyama Uriscale, and hands-on guidance. Right after discharge, participants will receive follow-up support via WhatsApp including educational videos.

Behavioral: Uriclarity Program

Control Group

NO INTERVENTION

Participants in this arm will receive standard lactation counseling provided by hospital staff before discharge. This includes general breastfeeding guidance but does not involve hands-on training, structured self-monitoring tools, or follow-up support after hospital discharge.

Interventions

Uriclarity Program BEHAVIORAL

The Uriclarity Program is a behavioral lactation support intervention designed to reduce the perception of insufficient milk supply (PIM) in postpartum women. The program consists of a two-hour hands-on training session delivered within the first 24-48 hours postpartum and a WhatsApp-based follow-up support system. During the in-person training, participants learn essential breastfeeding techniques, how to recognize normal lactation patterns, and how to use the Uriescala Ashiyama, a self-monitoring tool that evaluates neonatal urine color to assess milk transfer. Right after hospital discharge, participants receive virtual support including educational videos. This intervention differs from standard lactation counseling by integrating self-monitoring strategies, community-based digital support, and a non-technology-dependent educational approach, making it a scalable and sustainable strategy for breastfeeding promotion.

Uriclarity Program Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Crianzamor: lead

Study Sites (2)

Hospital de Chulucanas

Piura, Chulucanas, Peru

Location

Crianzamor

Piura, Piura, Peru

Location

Related Publications (5)

• Rodrigo R, Rodrigo A, Liyanage N, Hatahagoda W, Hewavitharana U. Maternal Perception of Adequacy of Mother's Milk Among Mothers Giving Birth at a Teaching Hospital in Sri Lanka. J Hum Lact. 2019 Feb;35(1):171-180. doi: 10.1177/0890334418773304. Epub 2018 May 22.

  PMID: 29787682 BACKGROUND

• Peacock-Chambers E, Dicks K, Sarathy L, Brown AA, Boynton-Jarrett R. Perceived Maternal Behavioral Control, Infant Behavior, and Milk Supply: A Qualitative Study. J Dev Behav Pediatr. 2017 Jul/Aug;38(6):401-408. doi: 10.1097/DBP.0000000000000455.

  PMID: 28570412 BACKGROUND

• Gatti L. Maternal perceptions of insufficient milk supply in breastfeeding. J Nurs Scholarsh. 2008;40(4):355-63. doi: 10.1111/j.1547-5069.2008.00234.x.

  PMID: 19094151 BACKGROUND

• Huang Y, Liu Y, Yu XY, Zeng TY. The rates and factors of perceived insufficient milk supply: A systematic review. Matern Child Nutr. 2022 Jan;18(1):e13255. doi: 10.1111/mcn.13255. Epub 2021 Aug 12.

  PMID: 34382733 BACKGROUND

• Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

  PMID: 26869575 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Jackeline Ashiyama Vega, NP

  Crianzamor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: May 28, 2025
• Primary Completion: August 24, 2025
• Study Completion: August 24, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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.
• Access Criteria: 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.

Locations

PE (2)