Labor, InducedSELECTIONNCT05838313
Should I Have an Elective Induction?
A study testing Elective Induction of Labor Decision Support Tool in people with Labor, Induced and Patient Preference, run by University of South Florida at 2 sites in United States.
Trial summary
The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation 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, Induced, Patient Preference
- What is being tested?
- Elective Induction of Labor Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pregnant person
- Nulliparous
- Planned vaginal delivery
- No medical indication for induction of labor
Who cannot join
- Contraindication to vaginal delivery
- Prior delivery (vaginal or cesarean)
- Medical indication for induction of labor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Should I Have an Elective Induction? The SELECTION Study
The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation
Read the detailed description
60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.
- Conditions
- Labor, Induced, Patient Preference
- Being tested
- Elective Induction of Labor Decision Support Tool
- Keywords
- Shared Decision Making
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Induction of Labor Decision Support ToolBehavioural
Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Decision Support Tool | Experimental | Participants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication Receives: Behavioral: Elective Induction of Labor Decision Support Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study
Measured: 32-38 weeks gestation
Proportion of People Completely Viewing the Decision Support Tool
The proportion of participants who view all of the pages of the decision support tool will be calculated
Measured: 36-38 weeks gestation
Secondary outcomes (3)
Satisfaction With the Decision Support Tool
4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
Measured: 36-38 weeks gestation
Satisfaction With the Decision Support Tool
4 item scale. Range of 0-20, with higher scores indicating higher satisfaction.
Measured: 38-39 weeks gestation, prior to delivery
Impact of App on Decision Making
5 point scale (Strongly disagree to Strongly agree, 5=Strongly agree) "Viewing the App affected my decision making"
Measured: 2-4 weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start22 Mar 2023
- Primary completion7 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor, InducedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of California, San Francisco, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838313
- Sponsor's protocol ID
- STUDY004944
- Other IDs
- R21HD098496
- Acronym
- SELECTION
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should I Have an Elective Induction? The SELECTION Study
- ClinicalTrials.gov ID
- NCT05838313
- Acronym / sponsor ID
- SELECTION / STUDY004944
- Conditions
- Labor, Induced, Patient Preference
- Keywords
- Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Ohio State University, University of California, San Francisco, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to perform a pilot test of a patient-centered decision support tool to help pregnant people and providers work together in making informed, shared decisions regarding whether or not to opt for elective IOL at 39 weeks gestation
Detailed description
60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not have an indication for induction of labor (IOL) will be enrolled and will view a decision support tool (DST) regarding induction without medical indication. During the enrollment face-to-face interview, participants will interact with the DST and complete pre- and post-DST viewing questionnaires. The investigators will conduct telephone interviews a few days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical record for delivery events and outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Support Tool | Experimental | Behavioral: Elective Induction of Labor Decision Support ToolParticipants will interact with the decision support tool prior to making their decision regarding whether to have an induction of labor without a medical indication |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant person
- Nulliparous
- Planned vaginal delivery
- No medical indication for induction of labor
Key exclusion criteria (3 listed)
- Contraindication to vaginal delivery
- Prior delivery (vaginal or cesarean)
- Medical indication for induction of labor
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 |
|---|---|---|
| Elective Induction of Labor Decision Support ToolDecision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor | Behavioural | Decision Support Tool |
Primary outcome
Recruitment Rate
Time frame: 32-38 weeks gestation
Recruitment rate, defined as the number of people who agree to participate out of those who are approached for the study
Proportion of People Completely Viewing the Decision Support Tool
Time frame: 36-38 weeks gestation
The proportion of participants who view all of the pages of the decision support tool will be calculated
3 secondary outcomes
Satisfaction With the Decision Support Tool
Time frame: 36-38 weeks gestation
Satisfaction With the Decision Support Tool
Time frame: 38-39 weeks gestation, prior to delivery
Impact of App on Decision Making
Time frame: 2-4 weeks Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective Induction of Labor Decision Support Tool in people with Labor, Induced and Patient Preference, run by University of South Florida at 2 sites in United States.
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 4 inclusion and 3 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Rate (time frame: 32-38 weeks gestation). 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 14 Jan 2025.