NCT06423534

Brief Summary

Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

March 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 16, 2024

Last Update Submit

May 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • A preformatted structured questionnaire

    It was developed by Tella et al. (2016) and comprised 12 questions that were assessed in various areas under various breastfeeding techniques practice.

    3 months

  • Self-Efficacy Scale - Short-Form (BSES-SF)

    It was adopted (Dennis, 2003) that assess maternal self-efficacy for breastfeeding throughout all stages of the study. The BSES-SF is a Likert scale with 14 items organized into two domains, namely: technical and intrapersonal thoughts.

    3 months

Study Arms (2)

Study GROUP

EXPERIMENTAL

Each primigravida in the study group during the last three trimesters will receive three sessions of knowledge, breast care, and breastfeeding technique after filling out a questionnaire (pretest). During 1 month from delivery, we will conduct a post-test with them (after 2 weeks and after 4 weeks) to explore the effect of breastfeeding health educational programs on practices and breastfeeding self-efficacy

Behavioral: Breastfeeding Health Educational Program

Control group

ACTIVE COMPARATOR

The control group was selected first and received a brochure leaflet delivered by the researcher. They didn't receive the health educational program

Behavioral: Breastfeeding Health Educational Program

Interventions

Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby. Therefore, this study will be conducted to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.

Control groupStudy GROUP

Eligibility Criteria

Age17 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
  • Primigravida mothers during last three trimester and 1 month after delivery
  • No problems during pregnant and have a healthy baby
  • Primigravida mothers who are not contraindicated to breastfeeding

You may not qualify if:

  • Multigravida mothers and pregnant women during first and second trimester

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Hail university

Hail, Saudi Arabia

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 21, 2024

Study Start

March 20, 2024

Primary Completion

July 15, 2024

Study Completion

August 10, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations