Assessment of Annabella Breast Pump Performance
1 other identifier
interventional
53
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedStudy Start
First participant enrolled
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 26, 2024
March 1, 2024
2.3 years
April 17, 2020
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Milk Volume collected using the breast pump
Total milk Volume (cc)
immediately after the intervention
Secondary Outcomes (1)
Satisfaction Satisfaction questionnaires
immediately after the intervention
Study Arms (2)
Anaabella
EXPERIMENTALMilk will be expressed using Annabella breast pump.
Control pump
ACTIVE COMPARATORMilk will be expressed using a control breast pump.
Interventions
Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)
Eligibility Criteria
You may qualify if:
- Women ≥ 18 years old
- Women whom are 2-5 months post delivery
- Lactating women - Breastfeed with no more than formula feeding twice a day and no solid food feeding (which replace breastfeeding) during the study period.
- Breastfeed or pumping at least 5 times a day
- Mother to healthy infant born at ≥ 37 weeks of gestation age.
You may not qualify if:
- Woman who consumes under 1,500 kcal/day (on a diet)
- Report a high mental stress condition and/or depression
- Use of estrogen oral contraceptives
- Pregnant women
- Suffer from chronic diseases that can impact breast feeding
- Participate in another clinical trial
- Mothers of babies who may develop feeding difficulties according to the investigator decisions (such as cleft pallet, autism).
- Woman with Sunken/ flat nipple or inverted nipple. or any other physiological condition that may disturb breast feeding.
- Woman that declares at time of recruitment that she is unable to extract more than 25ml per breastfeeding (overall from both breast)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shamir medical center
Be’er Ya‘aqov, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Revital Sheinberg, MD
Shiba Medical Center, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2020
First Posted
April 27, 2020
Study Start
December 30, 2020
Primary Completion
April 1, 2023
Study Completion
December 31, 2023
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share