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Enrolling by Invitation

NCT Number: NCT07479524

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Paul'S Hospital

Taoyuan, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decision aid

Device

decision aid

Primary outcomes

  1. Childbirth Self-Efficacy Inventory

    Time frame: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum

    There are a total of 62 questions, and the scoring method is based on Likert 10 points.

  2. State-Trait Anxiety Inventory; STAI

    Time frame: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum

    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".

Sponsors and collaborators

Lead sponsor

Lee Wan

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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