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

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ClinicalTrials.gov Identifier: NCT03528655
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Other: Decision aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Influence of Decision Aids on the Choice of Mother-infant Rooming-in or Separation Care for Pregnant Women : a Randomized Controlled Trial
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : January 31, 2020

Arm Intervention/treatment
Experimental: Decision aid group
Shared decision making using decision aid
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.

No Intervention: Controlled group
Standard oral explanation with booklet.



Primary Outcome Measures :
  1. Decision conflicts [ Time Frame: An average of 3 days after delivering ]
    Total score of decisional conflict scale


Secondary Outcome Measures :
  1. Decision regret [ Time Frame: An average of 3 days after delivering ]
    Total score of decision regret



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528655


Locations
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Taiwan
Ka-Wai Tam
New Taipei City, Taiwan, 23561
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Ka-Wai Tam, MD, PhD No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital
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Responsible Party: Ka-Wai Tam, Director of Shared Decision Making Resource Center, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03528655    
Other Study ID Numbers: N201802060
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital:
separation care
rooming-in care
patient decision aid