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

Breast Pumping Clinical Trial

Official title:

Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06222567
• Other study ID #: OLVG040
• Secondary ID: WO 22.168
• Status: Completed
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: August 18, 2023

Study information

• Verified date: January 2024
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 clinical indication to pump for reasons
• The subject signs the informed consent documentation

Exclusion Criteria:

• Woman is exclusively pumping
• Woman is still breastfeeding with the previous child
• Woman has been breastfeeding in the last 6 months

Related Conditions & MeSH terms

• Breast Pumping

Intervention

Device:
• 15 minutes pumping with INITIATE program
15 minutes pumping with INITIATE program
• 5 minutes extra pumping with MAINTAIN program
Additional 5 minutes extra pumping with MAINTAIN program

Locations

Country	Name	City	State
Netherlands	OLVG Hospital	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Onze Lieve Vrouwe Gasthuis	Medela AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total expression volume in milliliter		T1= 15 minutes, T2=20 minutes
Secondary	Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4)		T1= 15 minutes, T2=20 minutes