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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05796284
• Other study ID #: C202205166
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: National Defense Medical Center, Taiwan
• Contact: Lan Hsiang-Yun, A.P.
• Phone: +886287923100
• Email: shinnylan[@]msn.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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:

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: postpartum hemorrhage, infection, etc.;

4. Newborns with congenital abnormalities and major diseases;

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

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

Related Conditions & MeSH terms

• Breastfeeding
• Efficacy, Self
• Hyperemia
• Pregnancy Related

Intervention

Behavioral:
• Breast pressure relief intervention at the end of pregnancy
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 .

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

Locations

Country	Name	City	State
Taiwan	National defense medical center	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breast engorgement	the late pregnancy on the parturients' breast engorgement	Change from Baseline breast engorgement at 12 weeks after delivery.
Primary	The volume and speed of lactation	the late pregnancy on the parturients' lactation	Change from Baseline lactation at 12 weeks after delivery.
Primary	Breastfeeding Self-efficacy Scale Short Form	the late pregnancy on the parturients' breastfeeding	Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
Primary	Parental Self-efficacy Scale	the late pregnancy on the parturients' maternal competence	Change from Baseline Parental self-efficacy at 12 weeks after delivery.
Primary	Perceived Stress Scale	late pregnancy on the parturients' stress	Change from Baseline Perceived Stress Scale at 12 weeks after delivery.