Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women
1 other identifier
interventional
150
1 country
1
Brief Summary
During early postpartum period, mother-infant proximity is important for breastfeeding success. Rooming-in and separate care are both traditional practices. Rooming-in involves keeping the mother and the baby together in the same room after birth during hospitalization, whereas separate care keeps the baby in the hospital baby room. Shared decision making with decision aid (DA) is a way to provide information to pregnant women and to involve them in making decisions about their strategy on baby care. We have developed a DA to be administered during consultation for pregnant women, and conducted a randomized controlled trial (RCT) to evaluate the benefit of DA on decision making. The measurements include a battery of interview-based questionnaires and evaluations of decision regret. We expect the DA would benefit the intervention group in the aspects of knowledge and communication in choosing mother-baby care options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
1 active site
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
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedMarch 18, 2020
March 1, 2020
1.4 years
April 27, 2018
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decision conflicts
Total score of decisional conflict scale
An average of 3 days after delivering
Secondary Outcomes (1)
Decision regret
An average of 3 days after delivering
Study Arms (2)
Decision aid group
EXPERIMENTALShared decision making using decision aid
Controlled group
NO INTERVENTIONStandard oral explanation with booklet.
Interventions
Decision aid is a tool that helps pregnant women become involved in decision making on choosing rooming-in or separation care. Decision aid provides information about the options and outcomes, and by clarifying personal values.
Eligibility Criteria
You may qualify if:
- Women delivered by cesarean section or induction between 37 weeks, 0 days and 41 weeks, six days.
You may not qualify if:
- Pregnant women with preeclampsia, mental disorder, do not understand Chinese, and newborn baby with infection, or not suitable for rooming-in care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ka-Wai Tam
New Taipei City, 23561, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ka-Wai Tam, MD, PhD
No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Shared Decision Making Resource Center
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 18, 2018
Study Start
August 15, 2018
Primary Completion
December 30, 2019
Study Completion
January 31, 2020
Last Updated
March 18, 2020
Record last verified: 2020-03