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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03973476
Other study ID # P10/53-STAM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2012
Est. completion date December 31, 2017

Study information

Verified date April 2019
Source Jordi Gol i Gurina Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 31, 2017
Est. primary completion date December 31, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Phone care support by midwife
Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jordi Gol i Gurina Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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