NCT02106026

Brief Summary

An antenatal education intervention in primiparous women improves breastfeeding duration and reduces post-natal complications.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

March 28, 2014

Last Update Submit

April 2, 2014

Conditions

Keywords

BreastfeedingNursingPatient Education as TopicHealth Knowledge, Attitudes, PracticeHispanic Americans.

Outcome Measures

Primary Outcomes (2)

  • Breastfeeding duration

    At 6 months postpartum

  • Breastfeeding duration

    At 1 month postpartum

Secondary Outcomes (2)

  • Knowledge about breastfeeding and care of the breasts,

    Inmediate postpartum period.

  • Incidence of mothers with post-natal breast complications, such as cracks, breast lesions or mastitis

    At 1 month postpartum

Study Arms (2)

Conventional

NO INTERVENTION

All expectant mothers received the usual information about the advantages of maternal milk during pre-natal period. Nurses provided the information in personalized dialogue with the women during obstetric consultations.

Preventive education

EXPERIMENTAL

It was provided by the nurses during obstetric consultation in pre-natal period and averaged 30 minutes in duration. The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures. The nurses encouraged participation and gave the education in personalized dialogue with the woman. The information was reinforced with an illustrated explanatory leaflet.

Other: Preventive education

Interventions

The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures.

Preventive education

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primiparous women,
  • no contraindications to breastfeeding,
  • no skin disorders,
  • no breast surgery,
  • voluntary provision of data to enable their later localization.

You may not qualify if:

  • women who planned to deliver their babies in other hospitals,
  • twin pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast FeedingBehavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Study Officials

  • Concepcion Carratala-Munuera, PhD

    Universidad Miguel Hernandez de Elche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 7, 2014

Study Start

December 1, 2004

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

April 7, 2014

Record last verified: 2014-04