- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04135612
The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates
The Use of Smartphone Based Communication for Encouragement of Breastfeeding and Early Detection of Post-partum Depression- A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our study will aim to introduce a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team. This team will include: an obstetrician specialized in maternal-fetal medicine, a general obstetrician, two certified midwives, two certified lactation-consultants, a neonatologist, and a psychologist. Our vision and hypothesis for the current study- is that an intimate personalized daily communication and feedback platform between each woman and the support team will improve the rates of initiation of lactation and of full/partial lactation at various time points postpartum.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Holon, Israel
- Wolfson Medical Center
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H̱olon, Israel
- Wolfson Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women expressing wish to breastfeed, with singleton gestations, delivering > 37 weeks with no other maternal/neonatal significant morbidities.
Exclusion Criteria:
- refusal to participate
- no smartphone availability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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. |
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.
|
NO_INTERVENTION: Control group
The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
breastfeeding rates
Time Frame: 3 months
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Full or partial breastfeeding at fixed intervals.
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0026-19-WOMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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