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The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates

Primary Purpose

Breast Feeding, Exclusive, Post Partum Depression

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Smartphone based communication
Sponsored by
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Feeding, Exclusive

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wolfson medical center
  • Wolfson medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone group

Control group

Arm Description

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.

The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.

Outcomes

Primary Outcome Measures

breastfeeding rates
Full or partial breastfeeding at fixed intervals.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2019
Last Updated
February 15, 2021
Sponsor
Wolfson Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04135612
Brief Title
The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates
Official Title
The Use of Smartphone Based Communication for Encouragement of Breastfeeding and Early Detection of Post-partum Depression- A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We will aim to study the impact of introducing a smartphone-based daily feedback and communication platform between postpartum women delivering at our institute and a multidisciplinary breastfeeding-support team (obstetricians, neonatologists, midwives, lactation consultants, nurses, and psychologist) on breastfeeding rates.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Exclusive, Post Partum Depression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.
Intervention Type
Other
Intervention Name(s)
Smartphone based communication
Intervention Description
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.
Primary Outcome Measure Information:
Title
breastfeeding rates
Description
Full or partial breastfeeding at fixed intervals.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Wolfson medical center
City
Holon
Country
Israel
Facility Name
Wolfson medical center
City
H̱olon
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34871782
Citation
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.
Results Reference
derived

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The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates

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