Labor InductionNCT07479524
Effect of Induction Admission of Shared Decision-Making on First Time Expectant Mothers', Self-efficacy, Anxiety, Birth Outcomes and Birth Satisfaction
A study testing decision aid in people with Labor Induction, run by Lee Wan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- decision aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2025to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Those whose delivery method expected Cesarean Section
- Early water breaker
- Obstetric emergency
- Newborns have abnormal conditions
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- decision aid
- Keywords
- SDM, decision aids, labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision aidDevice
decision aid
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | routine education |
| shared decision making | Experimental | indcution of labor with shared decision making Receives: Device: decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Self-Efficacy Inventory
There are a total of 62 questions, and the scoring method is based on Likert 10 points.
Measured: 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".
Measured: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Oct 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee Wan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lee Wan, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479524
- Sponsor's protocol ID
- LWan
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Induction Admission of Shared Decision-Making on First Time Expectant Mothers', Self-efficacy, Anxiety, Birth Outcomes and Birth Satisfaction
- ClinicalTrials.gov ID
- NCT07479524
- Acronym / sponsor ID
- LWan
- Conditions
- Labor Induction
- Keywords
- SDM, decision aids, labor induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Lee WanUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –routine education |
| shared decision making | Experimental | Device: decision aidindcution of labor with shared decision making |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Those whose delivery method expected Cesarean Section
- Early water breaker
- Obstetric emergency
- Newborns have abnormal conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decision aiddecision aid | Device | shared decision making |
Primary outcome
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.
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing decision aid in people with Labor Induction, run by Lee Wan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Self-Efficacy Inventory (time frame: First pregnancy and the gestation period is more than 32 weeks to 3 days postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.