Clinical trial NCT04135612: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding, Exclusive
Post Partum Depression
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-22
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: breastfeeding rates
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
city: H̱olon
country: Israel
facility: Wolfson medical center
Study officials:
References:
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.