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Enrolling by invitation NCT07479524

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

No phase Interventional Labor Induction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: decision aid.
Who it may be relevant to
Registry conditions: Labor Induction. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device decision aid
    decision aid

Primary outcome measures

  • Childbirth Self-Efficacy Inventory [Time frame: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum]
  • State-Trait Anxiety Inventory; STAI [Time frame: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • Saint Paul'S Hospital — Taoyuan

Identifiers

NCT: NCT07479524 · LWan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗