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

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ClinicalTrials.gov Identifier: NCT04135612
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center

Tracking Information
First Submitted Date  ICMJE September 1, 2019
First Posted Date  ICMJE October 22, 2019
Last Update Posted Date October 22, 2019
Estimated Study Start Date  ICMJE November 8, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2019)
breastfeeding rates [ Time Frame: 3 months ]
Full or partial breastfeeding at fixed intervals.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Impact of a Daily Smartphone-based Communication Among Postpartum Women on Breastfeeding Rates
Official Title  ICMJE The Use of Smartphone Based Communication for Encouragement of Breastfeeding and Early Detection of Post-partum Depression- A Randomized Control Trial
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.

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized control trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Feeding, Exclusive
  • Post Partum Depression
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Smartphone based communication
  • No Intervention: Control group
    The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04135612
Other Study ID Numbers  ICMJE 0026-19-WOMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wolfson Medical Center
Study Sponsor  ICMJE Wolfson Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wolfson Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP