Effect of Induction Admission of Shared Decision-Making o... | NCT07479524

Studies
Effect of Induction Admission of Shared Decision-Making on First Time Expectant Mothers', Self-efficacy, Anxiety, Birth Outcomes and Birth Satisfaction

NCT07479524

Sponsor

Lee Wan

Status

Enrolling by invitation

Last Update Posted

Mar 18, 2026Actual

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Labor Induction

Interventions

decision aid

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Actual

Primary Completion Date

Jun 12, 2026Estimated

Completion Date

Jun 12, 2026Estimated

First Submitted Date

Mar 11, 2026

First Submission Date that Met QC Criteria

Mar 15, 2026

First Posted Date

Mar 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2026

Last Update Posted Date

Mar 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee Wan, National Taipei University of Nursing and Health Sciences, National Taipei University of Nursing and Health SciencesSponsor-Investigator

Lead Sponsor

Lee WanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women's childbirth is regarded as a natural, normal and healthy process, and no interventional measures are required unless medically necessary. However, the proportion of routine induction of labor among Taiwanese women is currently on the rise. This study intends to use the medical-patient shared decision-making program for induction of labor to explore the impact of this program on the delivery efficiency, anxiety, delivery results, and delivery satisfaction of first-time pregnant women. In addition, we also want to explore the feelings and thoughts of this group of women who underwent induced labor under the Shared Medical Decision-Making Program in the postpartum period after participating in this program. It can be used as an improvement reference for the future implementation of shared decision-making between doctors and clients.

This research adopts a qualitative and quantitative mixed research method to conduct this research. The quantitative research will adopt an experimental research design. Those who meet the criteria will be randomly assigned to collect the experimental group and the control group. In addition to receiving general routine care, the experimental group also receive a shared decision-making plan for delaying admission to the hospital. The control group received regular care. The results of measurement include knowledge about birth scale, anxiety scale, birth outcomes and birth satisfaction scale. The qualitative study is the application of one-to-one and in-depth interviews and semi-structured interview guidelines will be used to collect data, and the application of content analysis to analyze the data.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	No Intervention	routine education
shared decision making	Experimental	indcution of labor with shared decision making	Device: decision aid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
decision aid	Device	decision aid	shared decision making

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Childbirth Self-Efficacy Inventory	There are a total of 62 questions, and the scoring method is based on Likert 10 points.	First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum
State-Trait Anxiety Inventory; STAI	The Situational Anxiety Scale consists of 20 items; a higher score indicates a higher level of anxiety, and vice versa. This scale measures the subject's anxiety level using a 4-point scale: 1 point represents "not at all", 2 points represent "somewhat", 3 points represent "quite a bit", and 4 points represent "very much".	First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The first pregnancy and the gestation period is more than 32 weeks, the fetus is a singleton, and the fetal position is cephalad.
There are no obstetric complications and the fetus is normal during prenatal examination.
Can communicate in Mandarin and Taiwanese
Natural delivery is expected
Complete the consent form to participate in this study

Exclusion Criteria:

Those whose delivery method expected Cesarean Section
Early water breaker
Obstetric emergency
Newborns have abnormal conditions

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Paul'S Hospital		Taoyuan			Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D003661	Decision Support Techniques

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

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