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Completed

NCT Number: NCT05796284

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National defense medical center

Taipei, Taiwan, 114201

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Healthy pregnant women over 20 years old, without mental illness, and the number 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 accept long-term follower

Exclusion criteria

  • Pregnant women with a history of smoking, alcohol, and drug abuse;
  • Pregnant women have mental illness;
  • Maternal complications during childbirth or postpartum, such as: postpartum hemorrhage, infection, etc.;
  • Newborns with congenital abnormalities and major diseases;
  • Pregnant women who are unable or unwilling to breastfeed due to illness or other factors;
  • Refuse to accept breast compression intervention will be excluded from participating in the study

Treatment and study plan

Breast pressure relief intervention at the end of pregnancy

Behavioral

When teaching pregnant women, the researchers will use tablet computers and models to explain the operation of breast combing and acupressure one-on-one, and use the model to demonstrate. Emphasis on breast grooming during pregnancy, twice a day, once in the morning and evening, 5 minutes on one breast each time, 10 minutes on both sides; strengthen breast grooming and acupressure after delivery. The first breast combing, 5 minutes on one breast each time, and 10 minutes on both sides 4 to 6 times a day. After combing, according to expert advice, massage the 6 acupoints around the breast for 5-10 seconds, and then use hand expressing or breastfeeding to discharge the milk .

Routine care

Other

Cases in the routine care group received routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery.

Primary outcomes

  1. breast engorgement

    Time frame: Change from Baseline breast engorgement at 12 weeks after delivery.

    the late pregnancy on the parturients' breast engorgement

  2. The volume and speed of lactation

    Time frame: Change from Baseline lactation at 12 weeks after delivery.

    the late pregnancy on the parturients' lactation

  3. Breastfeeding Self-efficacy Scale Short Form

    Time frame: Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.

    the late pregnancy on the parturients' breastfeeding

  4. Parental Self-efficacy Scale

    Time frame: Change from Baseline Parental self-efficacy at 12 weeks after delivery.

    the late pregnancy on the parturients' maternal competence

  5. Perceived Stress Scale

    Time frame: Change from Baseline Perceived Stress Scale at 12 weeks after delivery.

    late pregnancy on the parturients' stress

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2023
Registry last updated
May 7, 2026

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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