The Management of Perceived Breastmilk Insufficiency

NCT04729166 | Completed

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized control trial was made to determine the effectiveness of structured education and follow-up in the management of perceived milk insufficiency among breastfeeding mothers.

Conditions

Breast Milk Expression; Breast Feeding, Exclusive

Keywords

breastmilk; breastfeeding; education; follow-up

Outcome Measures

Primary Outcomes (11)

• The starting breastfeeding in the first hour

  assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they started breastfeeding within the first hour after birth.

  Postpartum 3rd-7th day

• Bottle-feeding

  assessed using the Breastfeeding Follow-up Form in 3rd-7th day postpartum. Mothers reported whether they feed her baby with bottle-feeding.

  Postpartum 3rd-7th day

• The baby's amount of milk intake

  assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake.

  Postpartum 3rd-7th day

• The baby's amount of milk intake

  assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake.

  Postpartum the 1st month

• The baby's amount of milk intake

  assessed using The Scoring System for Measuring a Baby's Intake of Breast Milk. This measurement tool was developed to assess the amount of breast milk a baby is fed. The form is made up of 5 sections: the baby's weight, state of satisfaction, frequency and characteristics of urination and defecation and the condition of the mother's breasts. This tool is filled by observation, measurement and interview. The tool rates each status on the basis of 0, 1 or 2, the highest possible total score being 10. A score of 8-10 indicates that the intake of breast milk is good, 0-7 indicates an insufficient intake.

  Postpartum 2nd month

• Exclusively feeding with mother's milk

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.

  Postpartum 3rd-7th day

• Exclusively feeding with mother's milk

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.

  Postpartum the 1st month

• Exclusively feeding with mother's milk

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they feed her baby with exclusively mother's milk.

  Postpartum 2nd month

• Believing breast milk is adequate

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.

  Postpartum 3rd-7th day

• Believing breast milk is adequate

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.

  Postpartum the 1st month

• Believing breast milk is adequate

  assessed using the Breastfeeding Follow-up Form. Mothers reported whether they believed her baby take adequate breast milk.

  Postpartum 2nd month

Secondary Outcomes (12)

• Baby's height

  Postpartum 3rd-7th day

• Baby's height

  Postpartum 1st month

• Baby's height

  Postpartum 2nd month

• Believing the baby is adequately fed.

  Postpartum 3rd-7th day

• Believing the baby is adequately fed.

  Postpartum 1st month

Study Arms (2)

Study group

EXPERIMENTAL

The study group were provided with education with structured educational material and followed in this study, in addition to the usual care provided by healthcare professionals.

Behavioral: Structured education and follow-up

Control group

NO INTERVENTION

Control group was int the usual care.

Interventions

Structured education and follow-up BEHAVIORAL

This structured educational material was developed by the authors on the basis of the literature. Interventions of the study were carried out in the 32nd-42nd week of pregnancy, 3rd-7th day postpartum, and at the 1st month. At first stage, a 15-20-minute education was given to the pregnant women in the study group in the breastfeeding room of the facility, educational booklets were distributed. The main emphasis parts of the education were repeated with a standard summary information form at each follow-up.

Study group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women in their 32nd-42nd week of pregnancy
• Being literate in Turkish
• Being at least a primary school graduate

You may not qualify if:

• Having a history of psychological or mental health problems
• Having any condition in the mother or infant that was a barrier to breastfeeding
• The baby's admission into the neonatal unit
• The baby's separation from the mother for any reason

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Aydin, Efeler, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression; Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Zekiye Karaçam, Prof. Dr.

  Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

  STUDY CHAIR

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: Professor

Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)

Study Record Dates

• First Submitted: January 16, 2021
• First Posted: January 28, 2021
• Study Start: December 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)