Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Breast Feeding, Exclusive Post Partum Depression Other: Smartphone based communication Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Use of Smartphone Based Communication for Encouragement of Breastfeeding and Early Detection of Post-partum Depression- A Randomized Control Trial
Estimated Study Start Date : November 8, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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.

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.

No Intervention: Control group
The routine prenatal care provided by our institute includes lactation consulting during the 48-72 hour postpartum hospitalization.



Primary Outcome Measures :
  1. breastfeeding rates [ Time Frame: 3 months ]
    Full or partial breastfeeding at fixed intervals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135612


Locations
Layout table for location information
Israel
Wolfson medical center Recruiting
Holon, Israel
Contact: Hadas Miremberg, MD    972526741740    dasile2@gmail.com   
Wolfson medical center Recruiting
H̱olon, Israel
Contact: hadas miremberg, MD    972526741740    dasile2@gmail.com   
Sponsors and Collaborators
Wolfson Medical Center
Layout table for additonal information
Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT04135612    
Other Study ID Numbers: 0026-19-WOMC
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Behavioral Symptoms
Depressive Disorder
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications