Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados)

Not Applicable

Completed

• Conditions: Self Efficacy; Breast Feeding

• Registration Number: NCT03019484
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy promotion intervention. More specifically our objectives were to: explore changes in self-efficacy following the intervention; explore changes in the initiation and maintenance of breastfeeding following the intervention.

Detailed Description

Breastfeeding is the optimal choice for feeding infants in order to ensure a healthy growth and development. Although breastfeeding has many benefits for the infant and the mother, breastfeeding rates drop drastically during the first three months after birth. There is a number of factors that influence the initiation and maintenance of breastfeeding. One of the key factors is maternal self-efficacy in relation to breastfeeding. The aim of the study was the development and evaluation of an intervention to enhance maternal perceived self-efficacy in order to contribute positively to the initiation and maintenance of breastfeeding. This was done by using a complex intervention approach (MRC framework) to design and assess a multi-center controlled trial, involving midwives and nurses working at the Complejo Hospitalario de Navarra (CHN) of the Servicio Navarro de Salud and at the Clínica Universidad de Navarra (CUN). These health professionals were trained to deliver the intervention. The intervention was focused on self-efficacy related aspects and took place at three instances with every mother: in the final stage of pregnancy, during the maternal hospital stay after giving birth, and in the first days after discharge. The participants in the control group received the standard care as provided in each health institution.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-02
• Study Completion: 2015-11
• Study First Submitted: 2016-12-26
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• Intention to breastfeed and no contraindication to do so
• Speak Spanish
• Give informed consent

Exclusion Criteria

• Unwillingness to breastfeed
• Preterm birth (at <37 weeks gestation)
• Breastfeeding contraindication (galactosemia)
• Breastfeeding-related especial situations (multiple birth; newborn weight <2000g; leporine lip; newborn in intensive care unit)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes on Breastfeeding status reported by mothers	at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth	The mothers reported whether they were breastfeeding or not.
Changes on maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire	at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth	The mothers completed the questionnaire in person in T1 and by phone in T2, T3 and T4

Trial Locations

Locations (4)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Departamento de Ciencias de la Salud. Universidad Pública de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Facultad de Enfermería. Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain