NCT07098702

Brief Summary

This study aims to assess the effectiveness of ergonomic practices on quality of breastfeeding among primiparous.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Aug 2025

Status
not yet recruiting

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 Progress95%
Aug 2025Jul 2026

First Submitted

Initial submission to the registry

July 8, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

August 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 8, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Ergonomic Practices, Latch, Primiparous, Quality of Breastfeeding, Weight

Outcome Measures

Primary Outcomes (1)

  • A LATCH score

    A LATCH score of 0 to 3 is regarded as poor quality of breastfeeding, 4 to 7 is considered as moderate quality of breastfeeding, and 8 to 10 is considered as good quality of breastfeeding.

    At two weeks and two, four and six months after delivery

Secondary Outcomes (1)

  • Change in the growth chart of the infants

    At two weeks and two, four, and six months after delivery

Study Arms (2)

intervention group

EXPERIMENTAL

In this group, the mothers will receive educational sessions regarding appropriate ergonomic practices during breastfeeding which include appropriate body mechanics, breastfeeding positions and breastfeeding pillows

Other: educational sessions and booklet

control group

EXPERIMENTAL
Other: No Interventions

Interventions

educational sessions and booklet about ergonomic practices during breastfeeding which include appropriate body mechanics , breastfeeding positions, and use of breastfeeding pillows.

intervention group

In this group, the mothers will breastfeed their newborns according to the routine hospital postpartum instructions only.

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale pregnant mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) Nulliparous women, 2) Mothers between the ages of 18 and 35, 3) Mothers who are in the third trimester, 4) Singleton pregnancy, 5) Mothers who have the intention of breastfeeding, and 6) Mothers who can read and write.

You may not qualify if:

  • \) Mothers with nipple problems, such as flat or inverted nipples, and 2) Mothers with medical or surgical problems interfering with breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hanan El-Sayed Mohamed El-Sayed, Professor

    Faculty of Nursing, Mansoura University, Egypt

    STUDY CHAIR
  • Reda Abd El-Hady Ali Hemeda, Professor

    Faculty of Medicine, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR
  • Enas Sabry Fathy Elbeltagy, Lecturer

    Faculty of Nursing, Mansoura University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Mohamed Ali Abd-Ellatif Omar, Master student

CONTACT

Enas Sabry Fathy Elbeltagy, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor at Technical Institute of Nursing, Faculty of Nursing, Mansoura University

Study Record Dates

First Submitted

July 8, 2025

First Posted

August 1, 2025

Study Start

August 20, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share