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

An Interactive Web-based Decision Aid for Shared Decision Making: Birth Choice After Cesarean in Taiwan

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05091944
Enrollment
86
Registered
2021-10-25
Start date
2021-09-15
Completion date
2023-12-31
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shared Decision Making, Vaginal Birth After Cesarean

Keywords

communication aids, web-based decision aids

Brief summary

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.

Detailed description

Study design: A sequential mixed methods approach was conducted based on the Ottawa Decision Support Framework (ODSF). The current study will represent Aim 4 (Intervention implementation phase), comprising two stages. Stage 1 involves a randomized pre-test and post-test experimental design. Decisional conflict, knowledge, birth preference, and decision aid acceptability are assessed. Stage 2 consists of a survey, actual birth outcome and satisfaction are assessed. Setting and participants: The study will be conducted in a medical center in northern Taiwan. The medical center offers 24-hour system of the designated obstetrician. Using purposive sampling, the selection criteria include women who are medically eligible for VBAC in the study site, had experienced one previous CS, 14-16 weeks' gestation, had at least a half year interval between current pregnancy and the previous birth and are fluent in English or Mandarin. Exclusion criteria included women with multiple pregnancy, previous classic CS or myomectomy, and/or pregnancy with high risk of complications (for example, women who had risk factors such as hypertension, heart disease, diabetes, epilepsy, threatened premature labor, or another pre-existing medical problem). Randomization: Prior to the study commencing, the research team will conduct online discussions to clarify the research protocol. Eligible participants will be provided information about the study by the principal researcher and signed a written consent. Using computer permuted block randomization, participants will be allocated to control group (usual care) and intervention group (usual care plus the interactive web-based birth decision aid). After administering the baseline questionnaire, women will be allocated to the intervention group and give instructions by the principal researcher on how to log in the interactive birth decision aid platform/App. All participants confirm preferred mode of birth with their obstetrician prior to completing the second questionnaire. Usual care: A maternal health booklet, produced by Health Promotion Administration, Ministry of Health and Welfare, Executive Yuan, Taiwan, will be provided to all women. The booklet consists of 58 pages, presenting 5 Dos and 5 Don'ts during pregnancy. 5 Dos content included (1) Do receive prenatal exams according to schedule; (2) Do take good care during pregnancy; (3) Do recognize pregnancy complications; (4) Do know the signs of premature birth; (5) Do know the signs of labor. 5 Don'ts content included (1) Do not smoke or drink; (2) Do not be exposed to secondhand smoke; (3) Do not take medication without doctor's orders; (4) Do not choose a C-section in order to pick the time of birth; (5) Do not use drugs (52). There is very limited information relevant to mode of birth choice after caesarean. Intervention: Women in the intervention group will receive both usual care and decision support (an interactive web-based birth decision aid ). The interactive web-based birth decision aid will be modified from Professor Allison Shorten (English audio). We add communication aid at the beginning of platform/App. The communication aid comprises two components: components 1-how to participate in SDM and apply three talk to work together with clinicians (10 minutes) ; component 2-practice communication skill (10 minutes). Women will be assisted to create a unique username and password for secure decision aid access and its features and functions will be demonstrated. Intervention women will be invited to access the decision aid at home. All women are allowed to have many opportunities to access and use the decision aid during their pregnancy and will be recorded. They are encouraged to use the decision aid during recruitment and gestation visit in the Outpatient Department of Obstetrics. The principal researcher will provide 2-3 online consultations for individual women. Outcome measures : There are three primary and two secondary outcome measures. Primary outcome measures are decisional conflict, knowledge, birth preference and decision aid acceptability. Decisional conflict score (DCS)includes 16 questions in 5 sub-scale. Using the 5-point Likert 5 rating, from strongly agree ( 0 points) to strongly disagree (4 points). Knowledge measurement consists of a 15-item questionnaire asking participants to answer ''true,'' ''false,'' or ''unsure'' to a series of statements regarding risks and benefits of each birth mode. Previously tested Cronbach α for this questionnaire was = 0.67. Secondary outcome measures are actual birth outcome and satisfaction. Satisfaction with decision scale (SWD) included six questions to measure women's satisfaction with their decision, using the Likert 5 rating, from strongly agree (5 points) to strongly disagree (1 points). Women have higher scores indicating increased SWD. Cronbach's α previously tested was 0.88. Sample size : Using G-POWER 3.1.9.2 software, sample size was calculated. Based on estimates from a previous pilot study, effect size=.40, a total of sample size 156 provides α = .05 and power = .80. To allow for preterm deliveries, mal-presentations, and losses to follow-up, an increase in the desired number by 10 percent would be 172. Data collection and procedures : Eligible women will be invited to participate in the study when they attend prenatal examination at the 14-16 weeks' gestation visit in the Outpatient Department of Obstetrics and Gynecology. After participants sign written consent for participation, women will be allocated to either the intervention group or control group. All participants will complete personal basic information, decision conflict scale and knowledge scale in a quiet room. After completion of questionnaires, an interactive birth decision aid platform/App will be provided for intervention group women to discuss with their families at home. Individual consultations will be provided for intervention group women, by the principal researcher, at least twice during the 17-34 weeks' gestation period. All participants will complete decision conflict scale and knowledge scale and decision aid acceptability at 35-38 weeks' gestation. A follow-up is held one month after birth. Postnatal women will be asked about actual birth outcomes '' and complete a satisfaction questionnaire when they attend their postnatal examination visit . Data analysis: Quantitative data is managed and analyze using IBM SPSS Version 26.0. In terms of DCS and knowledge scores, matched pairs t-tests are used to compare differences between groups in change between pre and post test scores.

Interventions

DEVICEweb-based birth decision aid

Women in the intervention group receive both usual care and decision support (an interactive web-based birth decision aid). The innovative interactive web-based birth decision aid comprised five components: Component 1-a communication aid video involves 2 expert's talk about how to participate in SDM and prepare self with choice talk, option talk and decision talk(10 minutes )and practice communication skills with clinician(10 minutes); Component 2-overall of the function and features of birth decision aid. Component 3-introduce the benefits and risk of vaginal birth after cesarean; Component 4- the benefits and risk of elective repeat cesarean section; Component 5 -a quit to confirm women's knowledge regarding the two choices and confirm women's values.

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* pregnant women had experienced one previous cesarean * pregnant women had at least a half year interval between current pregnancy and the previous birth

Exclusion criteria

* women are multiple pregnancy * women had previous classic CS or myomectomy * pregnant women have high risk of complications

Design outcomes

Primary

MeasureTime frameDescription
change is being assessed-decisional conflict14-16 week gestation and 35-38week gestationDecisional conflict score (DCS)includes 16 questions. Using the 5-point Likert 5 rating, from strongly agree (0 points) to strongly disagree (4 points)
change is being assessed-knowledge14-16 week gestation and 35-38week gestationKnowledge measurement consists of a 15-item questionnaire asking participants to answer ''true,'' ''false,'' or ''unsure'' to a series of statements regarding risks and benefits of each birth mode
change is being assessed-birth preference14-16 week gestation and 35-38week gestationVBAC/ERCS
decision aid acceptability35-38week gestationDecision aid acceptability included nine questions to measure women's acceptability regarding decision aid , using the Likert 5 rating, from not at all (1 points) to a great deal (5 points)

Secondary

MeasureTime frameDescription
Actual birth outcomesone month after birthVBAC or ERCS
satisfaction of decisionone month after birthSatisfaction with decision scale (SWD) included six questions to measure women's satisfaction with their decision, using the Likert 5 rating, from strongly agree (5 points) to strongly disagree (1 points).

Countries

Taiwan

Contacts

Primary ContactShu Wen Chen, PhD
shuwen@ntunhs.edu.tw886-2-28227101
Backup ContactChang-Ching Yeh, PhD
ccyeh39@gmail.com886-2-28757826

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026