Assessment of Annabella Breast Pump Performance

Status Completed

Clinical Trial Summary

This is an interventional, prospective, randomized, comparative, two-period cross over study to evaluate the performance of Annabella breast pump against a control breast pump.

Clinical Trial Description

50 women who are 2-5 months post-delivery will be included in the study following appropriate consent. Women will be randomly allocated to two groups for the type of pump used on the first session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. Each expression visit will start approximately 3 hours after the end of a regular baby feeding session. During each visit, milk will be expressed once a day from each of the two breasts (left & right). During the 4 first visits (at least 1 day apart) Annabella or the control pump will be used. After at least 3 days washout period, milk will be expressed for additional 4 days, once a day from each of the two breasts, using the other breast pump. An expression session will last until no milk is expressed for 3 min continuously but not for longer than 25 min. Participants will be serving as their own control. Milk will be collected for volume and quality assessment. Maternal comfort at the end of each visit will be assessed using questionnaire. ;

Study Design

Related Conditions & MeSH terms

Breast Feeding

Clinical Trial Details

NCT number	NCT04363073
Study type	Interventional
Source	Annabella Tech Ltd
Contact
Status	Completed
Phase	N/A
Start date	December 30, 2020
Completion date	December 31, 2023

View Details

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