Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress

Last updated: May 10, 2024
Sponsor: National Defense Medical Center, Taiwan
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Breast pressure relief intervention at the end of pregnancy

Routine care

Clinical Study ID

NCT05796284
C202205166
  • Ages > 20
  • Female
  • Accepts Healthy Volunteers

Study Summary

The study purpose is to examine the effects of breast tenderness relief intervention during the late pregnancy on the parturients' breast engorgement, lactation, breastfeeding, maternal competence, and stress.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy pregnant women over 20 years old, without mental illness, and thenumber of pregnancy weeks has reached 36 weeks; 2. Full term production; 3.Literate or able to communicate in Chinese and Taiwanese; 4. After explaining,agree to participate in the research, sign the consent form, and acceptlong-term follower

Exclusion

Exclusion Criteria:

  1. Pregnant women with a history of smoking, alcohol, and drug abuse;

  2. Pregnant women have mental illness;

  3. Maternal complications during childbirth or postpartum, such as: postpartumhemorrhage, infection, etc.;

  4. Newborns with congenital abnormalities and major diseases;

  5. Pregnant women who are unable or unwilling to breastfeed due to illness or otherfactors;

  6. Refuse to accept breast compression intervention will be excluded from participatingin the study

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Breast pressure relief intervention at the end of pregnancy
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
July 31, 2025

Study Description

Background:

Maternal and child health is an important global health issue. Breast milk is the best food for infants and has many benefits for both mothers and infants. However, the breastfeeding rate in Taiwan has not increased but decreased in recent years. Breast engorgement and hypogalactia often cause distress for many women, and lead to stress and abandonment of breastfeeding, which in turn affects the achievement of motherhood. Therefore, nurses should provide support interventions for parturients early.

Methods:

This study is a two-years, prospective randomized controlled trial, and will adopt a longitudinal repeated-measures design. Convenience sampling will be used to recruit 180 pregnancy and postpartum women in the obstetrics clinic and postpartum ward of a medical center. The participants will be randomly assigned into two conditions (routine care and the breast tenderness relief intervention condition). The intervention will be provided to the participants from the 36th week of pregnancy until three months after delivery. Questionnaires, and biological measurements will be used to collect data. The outcome variables include the degree of breast engorgement, lactation, breastfeeding, maternal competencies, and stress. In addition, those data will be collected at the 36th and 38th week of pregnancy, three days, six weeks, and twelve weeks after childbirth. It is expected to analyze the research results with generalized estimation equation method.

Connect with a study center

  • National defense medical center

    Taipei, 114201
    Taiwan

    Active - Recruiting

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