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

NCT ID: NCT03528655

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2020-01-31

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Decision aid group

Shared decision making using decision aid

Group Type: EXPERIMENTAL

Decision aid

Intervention Type: OTHER

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.

Controlled group

Standard oral explanation with booklet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decision 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ka-Wai Tam

Director of Shared Decision Making Resource Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ka-Wai Tam, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital

Locations

Ka-Wai Tam

New Taipei City, , Taiwan

Countries

Taiwan

Other Identifiers

N201802060

Identifier Type: -

Identifier Source: org_study_id