Clinical trial NCT05796284: Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress
Official title: Effects of Breast Tenderness Relief Intervention During the Late Pregnancy on the Parturients' Breast Engorgement, Lactation, Breastfeeding, Maternal Competence, and Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Pregnancy Related
Efficacy, Self
Keywords: breast tenderness relief intervention
breast engorgement
breastfeeding
maternal efficacy
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: breast engorgement
timeFrame: Change from Baseline breast engorgement at 12 weeks after delivery.
measure: The volume and speed of lactation
timeFrame: Change from Baseline lactation at 12 weeks after delivery.
measure: Breastfeeding Self-efficacy Scale Short Form
timeFrame: Change from Baseline Breastfeeding Self-efficacy at 12 weeks after delivery.
measure: Parental Self-efficacy Scale
timeFrame: Change from Baseline Parental self-efficacy at 12 weeks after delivery.
measure: Perceived Stress Scale
timeFrame: Change from Baseline Perceived Stress Scale at 12 weeks after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National defense medical center
Study officials:
References: