NCT05091944

An Interactive Web-based Birth Decision Aid for Shared Decision Making

Status unknown NA Last updated 29 October 2021

What this trial tests

NA trial testing web-based birth decision aid in Shared Decision Making in 86 participants. Status unknown.

Timeline

15 September 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	National Taipei University of Nursing and Health Sciences
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	86
Start date	15 September 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• web-based birth decision aid

Conditions studied

• Shared Decision Making — all drugs for Shared Decision Making →
• Vaginal Birth After Cesarean — all drugs for Vaginal Birth After Cesarean →

Sponsor

National Taipei University of Nursing and Health Sciences

Who can join

Adults 20 to 45, female only, with Shared Decision Making or Vaginal Birth After Cesarean. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An interactive web-based decision aid for shared decision making: birth choice after cesarean in Taiwan

Background: Taiwan has a high national caesarean rate coupled with a low vaginal birth after caesarean (VBAC) rate. Studies suggest that pregnant women do not receive sufficient information about birth choices after caesarean in Taiwan and shared decision making (SDM) is not an expectation. Chen conducted a pilot study. Improvements in knowledge for the decision aid group were larger than for the usual care group, although differences between groups were not statistically significant. An interactive multimedia technology and humanity communication may provide opportunities to increase engagement and support women during decision consultations. Following previous pilot study, the study aims to examine the effectiveness of an interactive web-based birth decision aid for SDM in pregnant women who have had a previous cesarean.

Methods: A quantitative approach will be conducted with a randomized pre-test and post-test experimental design in a medical center in northern Taiwan. Participants who have had one previous CS will be recruited at 14-16 weeks. A total of 172 women will be completed a baseline survey and will be randomly allocated to either the intervention (usual care plus an interactive web-based birth decision aid ) or usual care (general maternal health booklet) group. A follow up survey at 35-38 weeks measured change in decisional conflict, knowledge, birth preference and decision aid acceptability. Actual birth outcomes and satisfaction will be assessed one month after birth.

Contributions/ Implementation of clinical practice The study will potentially increase women and obstetricians to support VBAC and SDM. The interactive decision aid tool may reduce time-consumption for health education. Linking web-based data analysis of AI into medical record can be beneficial for clinical practice and research in the future.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
2. An innovative web-based decision-aid about birth after cesarean for shared decision making in Taiwan: study protocol for a randomized control trial.
   Chen SW, Shorten A, Yeh CC, Kao CH, et al · · 2023 · cited 4× · PMID 36759893 · DOI 10.1186/s13063-023-07103-8