Clinical trial NCT06857461: Effect of the Uriclarity Program on Perceived Milk Supply in Postpartum Women in Piura-Peru
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perceived Insufficient Milk Supply
Keywords: Breastfeeding
Uriclarity Program
Perceived Insufficient Milk Supply
Lactation Support
Lead sponsor: Crianzamor
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Perceived Insufficient Milk Supply (PIM) Score
timeFrame: Baseline (Day 1), Day 3, Day 7, and Day 14 postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Piura
country: Peru
facility: Hospital de Chulucanas
state: Chulucanas
city: Piura
country: Peru
facility: Crianzamor
Study officials:
affiliation: Crianzamor
name: Jackeline Ashiyama Vega, NP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.