NCT04363073

Assessment of Annabella Breast Pump Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Annabella Tech Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Feeding

Interventions

Type	Name	Description
DEVICE	Annabella Breast Pump	Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
DEVICE	Control Breast Pump	Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

Timeline

• Start date: 2020-12-30
• Primary completion: 2023-04-01
• Completion: 2023-12-31
• First posted: 2020-04-27
• Last updated: 2024-03-26

Locations

1 site across 1 country: Israel