NCT06108154

Brief Summary

There is a significance difference in latch and Nipple-soreness score after intervention in control and interventional. Study population is primiparous mothers.group.interventional group received Breastfeeding supportive educational and training session.control group received hospital routine care.Randomised control trial designed selected. Sample size 60 participants. Latch and nipplesoreness rating scale used for data collection. statistical package of social sciences used for data analysis.outcome utilised in clinical and educative health care system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

September 28, 2023

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Demographical data, infant Latch on breast.

    Demographical data consisting of socio-demographic characteristics of participants 1: LATCH scoring system. A systematic breastfeeding assessment, diagnostic and evaluating tool for individual breastfeeding sessions. The tool assigns a numerical score, 0, 1, 2, and includes five key elements of breastfeeding.LATCH: 1. L for infant's ability to latch onto the breast, 2 .A for the presence of audible swallowing of the infant at the breast, 3.T for mother's nipple type, 4.C for mother's sense of comfort,5.H for holding.The total score range from 0 to 10; higher score, the more chances of successful effective breastfeeding. A LATCH score of 0-3 is regarded as poor, 4-7 as moderate/fair, and 8-10 as good/well, during early postpartum. The mothers observed for breastfeeding LATCH by 5-10 minute.

    One month

Secondary Outcomes (1)

  • Nipplesoreness

    One month

Study Arms (2)

Educational interventional Arm.

EXPERIMENTAL

Interventional arm received educational supportive breastfeeding and hand on training session on Latch techniques according to UNICEF guideline.

Behavioral: Educational breastfeeding traning session

Control routine hospital care Arm.

NO INTERVENTION

Control. No interventions receive hospital routine care

Interventions

Educational breastfeeding training session base on dialogical, visual attractive and training session on Proper LATCH techniques and breastfeeding positions to prevent from nipplesoreness.

Also known as: Breastfeeding hands on training session.
Educational interventional Arm.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous mothers.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous mothers in early postpartum with healthy infant outcomes.

You may not qualify if:

  • Sick mothers.
  • Mother with anomaly infants.
  • Mothers with contraindication for breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of health sciences lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Shazia Taj

    PG student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 1 SVD group divided into two sub groups. A) interventional.group and B)control group.2. LSCS group divided into two sub groups A)intervention, B)control group. observation compare for final result.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 30, 2023

Study Start

May 1, 2024

Primary Completion

July 10, 2024

Study Completion

July 20, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations