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Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women

Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women : a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03528655
Enrollment
150
Registered
2018-05-18
Start date
2018-08-15
Completion date
2020-01-31
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

separation care, rooming-in care, patient decision aid

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.

Detailed description

Background: 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. Using decision aid (DA) is one way to provide information to pregnant women and to involve them in making decisions about their mother-baby care approaches. Patients and Methods: Decision aids are interventions designed to help pregnant women to choose their options of mother-baby care by providing information on those options and any potential outcome relevant to different mother-baby care options. Pregnant women considering mother-baby care approaches are randomly assigned to receive a DA or the standard oral information (control condition) during consultation. By asking the pregnant women to look into a series of paired-comparisons, the DA leads the pregnant women to consider the competing attributes (i.e. specific risks/benefits) of the care options. The primary outcomes are decision conflicts and decision-making difficulties after consultation. Hypothesis: The pregnant women of the DAs group are predicted to have lower decisional conflict scores before labor and lower decision regret scores after labor compared with controlled women. Our study hopes to support the efficacy of DAs in helping pregnant women to arrive at mother-care decision.

Interventions

OTHERDecision aid

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.

Sponsors

Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Women delivered by cesarean section or induction between 37 weeks, 0 days and 41 weeks, six days.

Exclusion criteria

Pregnant women with preeclampsia, mental disorder, do not understand Chinese, and newborn baby with infection, or not suitable for rooming-in care.

Design outcomes

Primary

MeasureTime frameDescription
Decision conflictsAn average of 3 days after deliveringTotal score of decisional conflict scale

Secondary

MeasureTime frameDescription
Decision regretAn average of 3 days after deliveringTotal score of decision regret

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026