Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04135612 |
| Other study ID # |
0026-19-WOMC |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 30, 2019 |
| Est. completion date |
September 1, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Wolfson Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
