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Completed

NCT Number: NCT04729166

The Management of Perceived Breastmilk Insufficiency

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.

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Key information

Conditions

Breast Milk Expression Behavior Breast Feeding Breast Feeding, Exclusive Feeding Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Aydin, Efeler, 09100, Turkey (Türkiye)

About this study

Mothers 'perception of breastmilk insufficiency are important conditions affecting babies' exclusively breastfeeding in the first six months.

This study was made to determine the effectiveness of structured education and follow-up in the management of perceived breastmilk insufficiency among breastfeeding mothers. It was tested the hypotheses that there are no differences between mothers who have been provided with structured education and follow-up and those who have not received the education in terms of initiating breastfeeding in the first one hour, breastmilk insufficiency perceptions, the rate of exclusive feeding of breast milk to babies 0-2 months old, the baby's amount of milk intake and weight gain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. The starting breastfeeding in the first hour

    Time frame: Postpartum 3rd-7th day

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

  2. Bottle-feeding

    Time frame: Postpartum 3rd-7th day

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

  3. The baby's amount of milk intake

    Time frame: Postpartum 3rd-7th day

    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.

  4. The baby's amount of milk intake

    Time frame: Postpartum the 1st month

    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.

  5. The baby's amount of milk intake

    Time frame: Postpartum 2nd month

    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.

  6. Exclusively feeding with mother's milk

    Time frame: Postpartum 3rd-7th day

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

  7. Exclusively feeding with mother's milk

    Time frame: Postpartum the 1st month

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

  8. Exclusively feeding with mother's milk

    Time frame: Postpartum 2nd month

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

  9. Believing breast milk is adequate

    Time frame: Postpartum 3rd-7th day

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

  10. Believing breast milk is adequate

    Time frame: Postpartum the 1st month

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

  11. Believing breast milk is adequate

    Time frame: Postpartum 2nd month

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

Secondary outcomes

  1. Baby's height

    Time frame: Postpartum 3rd-7th day

    used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.

  2. Baby's height

    Time frame: Postpartum 1st month

    used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.

  3. Baby's height

    Time frame: Postpartum 2nd month

    used to determine the baby's height. Baby's height was measured and recorded by the researcher to The Breastfeeding Follow-up Form as cm.

  4. Believing the baby is adequately fed.

    Time frame: Postpartum 3rd-7th day

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

  5. Believing the baby is adequately fed.

    Time frame: Postpartum 1st month

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

  6. Believing the baby is adequately fed.

    Time frame: Postpartum 2nd month

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

  7. Being satisfied with baby's weight gain.

    Time frame: Postpartum 3rd-7th day

    assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.

  8. Being satisfied with baby's weight gain.

    Time frame: Postpartum 1st month

    assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.

  9. Being satisfied with baby's weight gain.

    Time frame: Postpartum 2nd month

    assessed using the Breastfeeding Follow-up Form. Mothers reported whether they were satisfied from her baby's weight gain.

  10. Baby's weight

    Time frame: Postpartum 3rd-7th day

    used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.

  11. Baby's weight

    Time frame: Postpartum 1st month

    used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.

  12. Baby's weight

    Time frame: Postpartum 2nd month

    used to determine the baby's weight. Baby's weight was measured and recorded by the researcher to The Breastfeeding Follow-up Form as grams.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Effectiveness of Structured Education and Follow-up on Management of Perceived Breastmilk Insufficiency: A Randomized Control Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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