AI-Based Oxytocin-Stimulated Smart Lactation Support Vest (NCT07765992) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AI-Based Oxytocin-Stimulated Smart Lactation Support Vest
76 participantsStarted 2026-12-01
Plain-language summary
AI-Based Oxytocin-Stimulated Smart Lactation Support Vest: Development of a Thermo-Massage and Vibration Wearable Vest Design to Support Milk Flow and Prevent Milk Duct Obstruction During Lactation
Who can participate
Age range
18 Years – 50 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:
For Mothers:
* Aged 18 years or older;
* Primiparous;
* Delivered by cesarean section;
* Singleton pregnancy;
* Delivered at 32-37 weeks of gestation;
* Newborn admitted to the Neonatal Intensive Care Unit (NICU);
* No medical condition that would prevent breast milk expression or use of the smart lactation support vest;
* Owns or has access to a smartphone;
* Willing to participate voluntarily and able to provide written informed consent;
* Able to read, understand, and communicate in Turkish.
For Newborns:
* Born at 32-37 weeks of gestation;
* No condition that would prevent the intake of breast milk.
Exclusion Criteria:
For Mothers:
* Body mass index (BMI) \>30 kg/m²;
* History of a psychiatric diagnosis or currently receiving psychiatric treatment (e.g., depression, schizophrenia, obsessive-compulsive disorder);
* Any medical condition that may interfere with breast milk expression (e.g., mastitis);
* Stillbirth;
* History of thyroid dysfunction;
* Any physical condition or disability that prevents wearing the smart lactation support vest;
* Previous breast surgery (e.g., breast implant surgery, mastectomy);
* Insufficient Turkish language proficiency preventing the participant from understanding and completing the study instruments.
For Newborns:
* Cleft palate or cleft lip;
* Congenital anomaly;
* Requirement for mechanical ventilation.
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
1
Daily Expressed Breast Milk Volume (mL/day)
Timeframe: Baseline (Day 0) through Day 10 postpartum