Perceived Insufficient Milk SupplyNCT06857461
Effect of the Uriclarity Program on Perceived Milk Supply in Postpartum Women in Piura-Peru
A study testing Uriclarity Program in people with Perceived Insufficient Milk Supply, run by Crianzamor at 2 sites in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perceived Insufficient Milk Supply
- What is being tested?
- Uriclarity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesPeru
- Study dates
- 28 May 2025to 24 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Perceived Insufficient Milk Supply
- Being tested
- Uriclarity Program
- Keywords
- Breastfeeding, Uriclarity Program, Perceived Insufficient Milk Supply, Lactation Support
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uriclarity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1), Day 3, Day 7, and Day 14 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 May 2025
- Primary completion24 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perceived Insufficient Milk SupplyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crianzamor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jackeline Ashiyama Vega, NP, Principal investigator, Crianzamor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857461
- Sponsor's protocol ID
- 202500001
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29787682Peacock-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.
PubMed 28570412Gatti 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.
PubMed 19094151Huang 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.
PubMed 34382733Victora 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.
PubMed 26869575
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06857461
- Acronym / sponsor ID
- 202500001
- Conditions
- Perceived Insufficient Milk Supply
- Keywords
- Breastfeeding, Uriclarity Program, Perceived Insufficient Milk Supply, Lactation Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- CrianzamorUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 24 Aug 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uriclarity Program Group | Experimental | Behavioral: Uriclarity ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uriclarity ProgramThe 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. | Behavioural | Uriclarity Program Group |
Primary outcome
Reduction in Perceived Insufficient Milk Supply (PIM) Score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 29787682Rodrigo 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.
- Background: PubMed 28570412Peacock-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.
- Background: PubMed 19094151Gatti 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.
- Background: PubMed 34382733Huang 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.
- Background: PubMed 26869575Victora 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackeline Ashiyama Vega, NP principal investigator
Crianzamor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uriclarity Program in people with Perceived Insufficient Milk Supply, run by Crianzamor at 2 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Perceived Insufficient Milk Supply (PIM) Score (time frame: Baseline (Day 1), Day 3, Day 7, and Day 14 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06857461, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.