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

Not Applicable

Completed

• Conditions: Breast Pumping
• Interventions: Device: 15 minutes pumping with INITIATE program; Device: 5 minutes extra pumping with MAINTAIN program

• Registration Number: NCT06222567
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief 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.

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.

Study Timeline

• Study Start: 2023-02-06
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pumping individual	15 minutes pumping with INITIATE program	Clinical indication for pumping
Pumping individual	5 minutes extra pumping with MAINTAIN program	Clinical indication for pumping

Primary Outcome Measures

Name	Time	Method
Total expression volume in milliliter	T1= 15 minutes, T2=20 minutes	Expressed milk volume in milliliters between 15 and 20 minutes of pumping

Secondary Outcome Measures

Name	Time	Method
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.	T1= 15 minutes, T2=20 minutes

Trial Locations

Locations (1)

OLVG Hospital; 🇳🇱 Amsterdam, Netherlands