NCT04135612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

September 1, 2019

Last Update Submit

February 15, 2021

Conditions

Breast Feeding, ExclusivePost Partum Depression

Outcome Measures

Primary Outcomes (1)

  • breastfeeding rates

    Full or partial breastfeeding at fixed intervals.

    3 months

Study Arms (2)

Smartphone group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Smartphone based communicationOTHER

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.

Smartphone group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women expressing wish to breastfeed, with singleton gestations, delivering \> 37 weeks with no other maternal/neonatal significant morbidities.

You may not qualify if:

  • refusal to participate
  • no smartphone availability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, Israel

Location

Related Publications (1)

  • 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.

    PMID: 34871782DERIVED

MeSH Terms

Conditions

Breast FeedingDepression, Postpartum

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized control trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2019

First Posted

October 22, 2019

Study Start

October 30, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 17, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)