CompletedNot Applicable

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

Peru91 participantsStarted 2025-05-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Perceived Insufficient Milk Supply (PIM) Score

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

Trial details

NCT IDNCT06857461

SponsorCrianzamor

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-24

View on ClinicalTrials.gov More Perceived Insufficient Milk Supply trials