Effect of the Uriclarity Program on Perceived Milk Supply in Postpartum Women in Piura-Peru
NCT ID: NCT06857461
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2025-05-28
2025-08-24
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Uriclarity Program Group
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.
Uriclarity Program
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.
Control Group
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.
No interventions assigned to this group
Interventions
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Uriclarity Program
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Crianzamor
OTHER
Responsible Party
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Principal Investigators
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Jackeline Ashiyama Vega, NP
Role: PRINCIPAL_INVESTIGATOR
Crianzamor
Locations
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Hospital de Chulucanas
Piura, Chulucanas, Peru
Crianzamor
Piura, Piura, Peru
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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202500001
Identifier Type: -
Identifier Source: org_study_id
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