NCT05687383

Brief Summary

This study will investigate the effectiveness of a modified product "safe breastfeeding pillow" in enhancing the comfort and safety of postpartum women during breastfeeding. The results of this study can be used as a reference to promote clinical practice and education on breastfeeding to prolong the duration of breastfeeding and to ensure the safety of newborns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

November 28, 2023

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

January 4, 2023

Last Update Submit

November 25, 2023

Conditions

BreastfeedingPregnancy RelatedNewborn; FitSafety Issues

Keywords

BreastfeedingPillowSafety issuesComfortNewbornPregnancy

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale (BSES)

    A 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence

    through study completion, an average of 2-7 days

Secondary Outcomes (3)

  • Breastfeeding safety scale

    through study completion, an average of 2-7 days

  • Body Part Discomfort Scale (BPDS)

    through study completion, an average of 2-7 days

  • B-R-E-A-S-T-Feed scale

    through study completion, an average of 2-7 days

Study Arms (2)

Safe breastfeeding pillow

EXPERIMENTAL

Safe breastfeeding pillow increase the comfort and safety of postpartum women during breastfeeding, thereby prolonging breastfeeding and ensuring optimal nutrition for the baby

Device: Safe breastfeeding pillow

Breastfeeding pillow

PLACEBO COMPARATOR

Providing a comfortable, supportive and safe environment for healthier and breastfeeding for women and babies

Device: Safe breastfeeding pillow

Interventions

Safe breastfeeding pillowDEVICE

A randomized controlled trial

Also known as: Breastfeeding pillow
Breastfeeding pillowSafe breastfeeding pillow

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal spontaneous delivered mothers without serious postpartum complications.
  • Normal newborns who can breastfeed.
  • The mother is willing to breastfeed at least 3 times in the cradle position during the hospital stay.
  • Mothers can communicate in Chinese and Taiwanese.
  • Agree to participate in the study and complete the informed consent form.

You may not qualify if:

  • Infants who cannot continue breastfeeding due to condition changes after birth.
  • Mothers who cannot continue breastfeeding due to medical reasons after childbirth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 18, 2023

Study Start

April 11, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

November 28, 2023

Record last verified: 2022-12

Locations

TW(1)