Effectiveness of Midwife Phone Support With the to Reduce the Early Abandonment of Breastfeeding (STAM)

Objective: To evaluate the effectiveness of telephone support of the reference midwife, in relation to the abandonment of breastfeeding of primiparous mothers and to identify, both the risk factors and the protective factors for the early abandonment of breastfeeding.

Material and Method Randomized parallel controlled clinical trial.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Phone care support by midwife

Detailed Description

Sample: 220 primiparous mothers with access, during the 8 weeks postpartum, to a mobile phone to contact the midwife randomization of 110 mothers to the experimental group and 110 to the control group. The mothers of the experimental group will be offered the mobile phone number to contact their midwife after delivery. The mothers of the control group will receive the usual attention of the portfolio of services that includes the spontaneous visit in the center, the telephone call in the center, the home visit and the health education groups.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Primiparians who carry out the follow-up of pregnancy for the midwife
• The pregnant woman is of low risk
• Possibility of the mother to make calls to the mobile phone.
• The pregnant woman wishes to participate in the study.

Exclusion Criteria

• Maternal or fetal pathology that can condition maternal breastfeeding.
• idiomatic barrier.
• Prematurity.
• Baby with weight <2,500 gr. at birth
• Home delivery during the puerperium

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Mothers received a phone support service with their midwife during the 8 weeks after childbirth.	Other: Phone care support by midwife; Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.
NO_INTERVENTION: Control group; Mothers received standard postpartum care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who breast-feed at 3 months of intervention	Women who still breastfeed 3 months after the intervention with respect to the control arm	3 months

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2012
• Primary Completion (ACTUAL): December 31, 2014
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: phone support; midwife; early abandonment of breastfeeding
• Other Study ID Numbers: P10/53-STAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No