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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03528655
• Other study ID #: N201802060
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 31, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Ka-Wai Tam	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision conflicts	Total score of decisional conflict scale	An average of 3 days after delivering
Secondary	Decision regret	Total score of decision regret	An average of 3 days after delivering