NCT05271812

Brief Summary

Background The long-term benefits of breastfeeding for newborns and mothers are undeniable and scientifically recognized. Current WHO/UNICEF guidelines suggest increasing exclusive breastfeeding to 75.0% by 2030 worldwide. However, there is substantial heterogeneity in breastfeeding practices around the world. Because while breastfeeding promotion is complex, breastfeeding instructions remain without any educational design in general. Primary Objective: \- Determine the effectiveness of breastfeeding educations among the nursing mothers during first month after childbirth. Secondary objectives:

  • Identify the theoretical and pedagogical engineering framework the breastfeeding educations proposed in antenatal among nursing mothers and professionals.
  • Assess the perceived usefulness of nursing mothers regarding to the educational interventions for breastfeeding management and its frequently complications.
  • Assess the perceived usefulness of professionals, regarding to the pedagogical engineering of educational interventions offered to nursing mothers.
  • Assess women's competency regarding to the educational interventions for breastfeeding management and its frequently complications.
  • Evaluate the organization of educational interventions proposed by professionals. Method \& Results: The results will be obtained by calculating the mean, standard deviation, median and interquartile range. The Chi-square and Yates' uncorrected and corrected tests will be applied for comparison calculation. Evaluating criteria for feeling of usefulness and breastfeeding competency will be studied using Likert's four level model, 10-Point numerical scales and short answer questions. The relationships between these variables will be studied by using a sequential mixed method combining interpretative, comprehensive, and explanatory approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 28, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

February 28, 2022

Last Update Submit

February 28, 2022

Conditions

Keywords

Breastfeeding educationHealth promotionEducational technics

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of breastfeeding educations among mothers during first month after childbirth.

    The proportion of nursing mothers receiving the breastfeeding education.

    First month after birth

Study Arms (2)

Mothers

All women delivered in the recruitment center

Staff

All staff working in the labor and delivery areas of the recruiting center.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who delivered in the Armand Trousseau Maternity Staff who working in the Armand Trousseau Maternity

You may qualify if:

  • \- For nursing mothers: Healthy mothers and healthy new-born Upper 18 years old French speaking Agree to be interviewed in two steps: at day 3 \&1 month after the birth.
  • For Staff: Agree to be interviewed during study

You may not qualify if:

  • \- For nursing mothers: Bottle feeding or mixed breastfeeding. Premature new-born or hospitalised in neonatology ward. Refusing to participate
  • \- For Staff: Refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital TROUSSEAU

Paris, Ap-hp, 75012, France

Location

Related Publications (1)

  • Yazdanbakhsh M, De Andrade V, Spiesser-Robelet L, Gagnayre R. The need for educational intervention for breastfeeding women and the professional practice of midwives in France to promote breastfeeding: A joint explanatory study. Eur J Midwifery. 2024 Dec 11;8. doi: 10.18332/ejm/191176. eCollection 2024.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Mehrnoosh Yazdanbakhsh

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehrnoosh Yazdanbakhsh

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

March 1, 2022

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations