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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related||Other: Decision aid||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|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|
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.
- Decision conflicts [ Time Frame: An average of 3 days after delivering ]Total score of decisional conflict scale
- Decision regret [ Time Frame: An average of 3 days after delivering ]Total score of decision regret
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
|New Taipei City, Taiwan, 23561|
|Principal Investigator:||Ka-Wai Tam, MD, PhD||No.291, Zhongzheng Rd., Zhonghe , Taipei 23561, Taiwan. Shuanghe Hospital|