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Completed

NCT Number: NCT04363073

Assessment of Annabella Breast Pump Performance

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.

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Key information

Conditions

Breast Feeding Behavior Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shamir medical center

Be’er Ya‘aqov, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Annabella Breast Pump

Device

Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)

Control Breast Pump

Device

Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)

Primary outcomes

  1. Milk Volume collected using the breast pump

    Time frame: immediately after the intervention

    Total milk Volume (cc)

Secondary outcomes

  1. Satisfaction Satisfaction questionnaires

    Time frame: immediately after the intervention

    rating scale: Min: 1 , Max: 10; higher score- better outcome

Sponsors and collaborators

Lead sponsor

Annabella Tech Ltd

Industry

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2020
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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