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 range18 Years

SexFEMALE

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

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