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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaabella | Experimental | Milk will be expressed using Annabella breast pump. |
|
| Control pump | Active Comparator | Milk will be expressed using a control breast pump. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Annabella Breast Pump | Device | Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Milk Volume collected using the breast pump | Total milk Volume (cc) | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Satisfaction questionnaires | rating scale: Min: 1 , Max: 10; higher score- better outcome | immediately after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Revital Sheinberg, MD | Shiba Medical Center, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shamir medical center | Be’er Ya‘aqov | Israel |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| Control Breast Pump | Device | Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart) |
|