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

Not Applicable

Recruiting

• Conditions: Breastfeeding; Efficacy, Self; Pregnancy Related
• Interventions: Behavioral: Breast pressure relief intervention at the end of pregnancy; Other: Routine care

• Registration Number: NCT05796284
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Study Timeline

• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-08-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast pressure relief intervention at the end of pregnancy	Routine care	The "Breast Compression Intervention at the End of Pregnancy" group is expected to start after the 36th week of pregnancy and continue until three months after delivery. In addition to routine care, breast relaxation methods of different intensities during pregnancy and postpartum will be provided in stages.
Routine care group	Routine care	Cases in the routine care group receive routine prenatal care and guidance during weekly outpatient checkups, and routine postpartum care and guidance after delivery, including breastfeeding posture and skills, hand expression, and breast milk storage methods, etc.
Breast pressure relief intervention at the end of pregnancy	Breast pressure relief intervention at the end of pregnancy	The "Breast Compression Intervention at the End of Pregnancy" group is expected to start after the 36th week of pregnancy and continue until three months after delivery. In addition to routine care, breast relaxation methods of different intensities during pregnancy and postpartum will be provided in stages.

Primary Outcome Measures

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

Trial Locations

Locations (1)

National defense medical center; 🇨🇳 Taipei, Taiwan