Health TrialsbyHealthPanel

AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

ConditionsLactationLactation Disorder - Postpartum Condition or ComplicationBreast Feeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSelcuk University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older;

Primiparous;

Delivered by cesarean section;

Singleton pregnancy;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Based Oxytocin-Stimulated Smart Lactation Support Vest

    Device

    Participants assigned to the intervention group will use the AI-based oxytocin-stimulated smart lactation support vest for 10 days, three times daily, in addition to standard lactation care and counseling. Each session will consist of 5 minutes of heating, 15 minutes of heating combined with massage, and 10 minutes of heating combined with massage and vibration. The wearable vest is designed to provide controlled thermo-massage and vibration stimulation to support milk flow and lactation during the early postpartum period. The system includes temperature and bioelectrical impedance sensors and an AI-based decision-support module intended to provide individualized recommendations regarding stimulation parameters.

  • Standard Lactation Care and Counseling

    Behavioral

    Participants assigned to the control group will receive standard lactation care and counseling according to the hospital protocol. Standard care will include routine lactation counseling, guidance regarding breastfeeding and milk expression, breast care, storage of expressed breast milk, daily reminders to express milk, and lactation support when clinically indicated.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Arm 1 - InterventionExperimental treatment 1 intervention
Group B: Arm 2 - ControlActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Daily Expressed Breast Milk Volume (mL/day)

The amount of breast milk expressed by the mother per day, measured in milliliters (mL/day) during the 10-day follow-up period.

Time frame
Baseline (Day 0) through Day 10 postpartum

Secondary outcomes

1

Maternal Serum Oxytocin Level (pg/mL)

Maternal serum oxytocin concentration measured using laboratory analysis.

Time frame
Baseline, Day 5, and Day 10
2

Maternal Serum Prolactin Level (ng/mL)

Maternal serum prolactin concentration measured using laboratory analysis.

Time frame
Baseline, Day 5, and Day 10
3

Maternal Serum Cortisol Level (µg/dL)

Maternal serum cortisol concentration measured using laboratory analysis.

Time frame
Baseline, Day 5, and Day 10
4

Breast Fullness

Breast fullness assessed using the Breast Fullness Assessment Scale. The scale consists of one item scored from 1 to 6, with higher scores indicating greater breast fullness and sensitivity.

Time frame
Day 1 through Day 10

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Selcuk University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: