The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates
NCT ID: NCT04135612
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
224 participants
INTERVENTIONAL
2019-10-30
2020-09-01
Brief Summary
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Detailed Description
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Geographic area - A university affiliated hospital in southern Tel-Aviv that serves a population of over 500,000 people. Our annual delivery volume is 5000 deliveries with a 22% CS rate. The population is heterogeneous and consists of a high rate of women with intermediate-low income as well as a population of refugees from Africa (mostly Eritrea), both populations still have a very high rate of smartphone owners based on our previous experience.
Methods- Prospective, single-center randomized controlled trial. Eligibility will be limited to women expressing wish to breastfeed, with singleton gestations, delivering \> 37 weeks with no other maternal/neonatal significant morbidities.
Study design and group assignment -Women meeting inclusion criteria who own a smartphone will be approached for recruitment on postpartum day 1. After obtaining a written informed consent, patients will be randomly assigned either to the intervention group (smartphone group) or to the control group in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.
The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization. Patients allocated to the control group will receive the aforementioned care. Patients assigned to the smartphone group will receive our standard care, and in addition will have an application installed to their smartphones. This application will be in Hebrew language, simple to use, and specifically designed to the needs of the current study.
All patients will receive a demonstration regarding the use of the application from one of our research coordinators, in addition to a detailed information brochure.
the patient will receive via email an individualized feedback from our team regarding her lactation. This feedback could include: reassurance and positive feedback and lactation tips in attempt to optimize specific obstacles. In addition, patients will be encouraged to use the platform to ask questions and receive immediate answers regarding any aspect lactation.
Primary outcome- Lactation at 3 months postpartum Secondary outcomes Full/partial lactation at 2 weeks, 4 weeks, 6 weeks, 3 months, and 6 months and a variety of outcomes regarding neonatal health, maternal health, emotional status and satisfaction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Smartphone group
application installed to their smartphones. This application will be in Hebrew language, simple to use, and specifically designed to the needs of the current study.
Each patient will document each evening her lactation performance during the day, and the App will generate a daily report transmitted by email every evening to our computerized research database. Every evening the patient will receive via email an individualized feedback from our team regarding her lactation. This feedback could include: reassurance and positive feedback and lactation tips in attempt to optimize specific obstacles. In addition, patients will be encouraged to use the platform to ask questions and receive immediate answers regarding any aspect lactation. As per the study protocol, medical treatment will only be initiated in a formal clinic appointment and not via the application.
Smartphone based communication
Each patient will document each evening her lactation performance during the day, and the App will generate a daily report transmitted by email every evening to our computerized research database. Every evening the patient will receive via email an individualized feedback from our team regarding her lactation. This feedback could include: reassurance and positive feedback and lactation tips in attempt to optimize specific obstacles.
Control group
The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.
No interventions assigned to this group
Interventions
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Smartphone based communication
Each patient will document each evening her lactation performance during the day, and the App will generate a daily report transmitted by email every evening to our computerized research database. Every evening the patient will receive via email an individualized feedback from our team regarding her lactation. This feedback could include: reassurance and positive feedback and lactation tips in attempt to optimize specific obstacles.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* no smartphone availability
18 Years
50 Years
FEMALE
Yes
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Locations
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Wolfson medical center
Holon, , Israel
Countries
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References
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Miremberg H, Yirmiya K, Rona S, Gonen N, Marom O, Pohol A, Kovo M, Bar J, Weiner E. Smartphone-based counseling and support platform and the effect on postpartum lactation: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Mar;4(2):100543. doi: 10.1016/j.ajogmf.2021.100543. Epub 2021 Dec 4.
Other Identifiers
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0026-19-WOMC
Identifier Type: -
Identifier Source: org_study_id
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