CompletedNot Applicable

Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card

Netherlands80 participantsStarted 2021-01-05

Plain-language summary

The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.

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: * Subject ≥ 18 years old * Infant was born maximum 4 (96 hours) days ago * Subject aims to provide breastmilk for the baby through breastfeeding. * At least 50% of the milk removal sessions in the last 24hrs were breastfeeds. * Subject has an indication to pump for reasons * The subject signs the informed consent documentation Exclusion Criteria: * Woman is exclusively pumping * Woman is experiencing a mastitis event * Woman is still breastfeeding with the previous child * Woman has been breastfeeding in the last 6 months * Woman received morphine pain medication in the last 8 hours

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

Occurrence of adverse events

Timeframe: during the 20 minutes pumping procedure. this is the only visit and task for the patient.

Comfort while pumping

Timeframe: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.

Trial details

NCT IDNCT04619212

SponsorMedela AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-07

View on ClinicalTrials.gov More Breast Pumping trials