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

NCT07479524 | Enrolling By Invitation DMC

• 1 other identifier: LWan
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Induction

Keywords

SDM; decision aids; labor induction

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

control group

NO INTERVENTION

routine education

shared decision making

EXPERIMENTAL

indcution of labor with shared decision making

Device: decision aid

Interventions

decision aid DEVICE

decision aid

shared decision making

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lee Wan: lead

Study Sites (1)

Saint Paul'S Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Taipei University of Nursing and Health Sciences

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 18, 2026
• Study Start: October 1, 2025
• Primary Completion: June 12, 2026
• Study Completion: June 12, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

TW (1)