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CompletedNCT06222567Updated Jan 24, 2025

Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery

An interventional study of 15 minutes pumping with INITIATE program and 5 minutes extra pumping with MAINTAIN program in Breast Pumping, sponsored by Onze Lieve Vrouwe Gasthuis. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by Onze Lieve Vrouwe Gasthuis · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2023, registered Jan 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.

Read the detailed description

This study aims to assess if expression milk volume could be improved for patients pumping milk for a clinical indication by implementing five minutes more pumping with the MAINTAIN program, a different sucking pattern, to initiate and benefit milk production. The results of this study will provide important information that validates the proposed changes as well as build clear recommendation for using the Symphony program cards in this population.

02

Conditions studied

  • Breast Pumping
03

In context

Lead sponsor

Onze Lieve Vrouwe Gasthuis is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Subject ≥ 18 years old
  • Infant was born maximum 4 (96 hours) days ago
  • Subject has an clinical indication to pump for reasons
  • The subject signs the informed consent documentation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Pumping individual

    Clinical indication for pumping

    Device: 15 minutes pumping with INITIATE program · Device: 5 minutes extra pumping with MAINTAIN program

Interventions

  • Device15 minutes pumping with INITIATE program

    15 minutes pumping with INITIATE program

  • Device5 minutes extra pumping with MAINTAIN program

    Additional 5 minutes extra pumping with MAINTAIN program

06

What researchers measure

Primary outcomes

  1. Total expression volume in milliliter

    Expressed milk volume in milliliters between 15 and 20 minutes of pumping

    Time frame: T1= 15 minutes, T2=20 minutes

Secondary outcomes

  1. Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4) and patient characteristic. Milk yielded in milliliters per minute after 15 and 20 minutes pumping.

    Time frame: T1= 15 minutes, T2=20 minutes

07

Study locations

1 site
  • OLVG Hospital
    Amsterdam, Netherlands
08

References and documents

Individual participant data

Plan to share: No — Individual data is not shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06222567
Lead sponsor
Onze Lieve Vrouwe Gasthuis
Collaborators
Medela AG
Responsible party
Sponsor
First posted
Jan 24, 2024
Start date
Feb 6, 2023
Primary completion
Aug 18, 2023
Completion
Aug 18, 2023
Last update
Jan 24, 2025

Study contacts

Fedde Scheele, Prof. Dr.
principal investigator · OLVG Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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