NCT03973476

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 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

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

April 29, 2019

Last Update Submit

June 3, 2019

Conditions

Breastfeeding

Keywords

phone support; midwife; early abandonment of breastfeeding

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Mothers received a phone support service with their midwife during the 8 weeks after childbirth.

Other: Phone care support by midwife

Control group

NO INTERVENTION

Mothers received standard postpartum care

Interventions

Phone care support by midwifeOTHER

Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.

Intervention group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

June 4, 2019

Study Start

January 1, 2012

Primary Completion

December 31, 2014

Study Completion

December 31, 2017

Last Updated

June 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share