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

T

Taipei Medical University

Status

Completed

Conditions

Pregnancy Related

Treatments

Other: Decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT03528655
N201802060

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Decision aid group
Experimental group
Description:
Shared decision making using decision aid
Treatment:
Other: Decision aid
Controlled group
No Intervention group
Description:
Standard oral explanation with booklet.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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