Assessment of Annabella Breast Pump Performance (NCT04363073) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Annabella Breast Pump Performance
Israel53 participantsStarted 2020-12-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.