Labour AnalgesiaPrepDMNCT07516171
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
A study testing Preparation for Decision Making (PrepDM) Scale and Questionnaire in people with Labour Analgesia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- Preparation for Decision Making (PrepDM) Scale and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant individuals ≥ 18 years
- Visiting OB clinic at Mount Sinai hospital during their 3rd trimester of pregnancy (≥ 28 weeks gestation)
- Singleton gestation
- Nulliparous
- Considering labour epidural analgesia for childbirth
Who cannot join
- Sensory, cognitive, or language barriers precluding participation
- Limited English proficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Ronald George, MD, 416-586-4800 ext. 2681, ron.george@uhn.ca
Kristi Downey, MSc, 416-586-4800 ext. 2366, kristi.downey@uhn.ca
About this study
Official title: A Randomized Controlled Trial of a Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information.
The Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour.
This trial aims to evaluate whether directing patients to access to the website https://thepainlesspush.com/ improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.
- Conditions
- Labour Analgesia
- Being tested
- Preparation for Decision Making (PrepDM) Scale, Questionnaire
- Keywords
- labour pain, education
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparation for Decision Making (PrepDM) ScaleOther
Electronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100.
QuestionnaireOther
Electronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale.
| Study group | Role | What they receive |
|---|---|---|
| Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website | Other | Comparator: The Painless Push digital resource educates mothers about ways to manage pain during labour. Receives: Other: Preparation for Decision Making (PrepDM) Scale; Other: Questionnaire |
| Mount Sinai Obstetric Anesthesia website | Other | Control group: website currently available to patients. Receives: Other: Preparation for Decision Making (PrepDM) Scale; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation for Decision Making (PrepDM) score
PrepDM is a 10-item validated tool scored from 0 to 100. Higher scores reflect greater readiness for informed and shared decision-making
Measured: Immediately following intervention (reading material)
Secondary outcomes (1)
Questionnaire - additional questions about digital material provided
Additional questions about the clarity of the information, perceived understanding, likelihood of recommending, and intent to engage in shared decision-making in future health decisions.
Measured: Immediately following intervention (reading material)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour AnalgesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald George, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516171
- Sponsor's protocol ID
- 26-01
- Acronym
- PrepDM
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- A Randomized Controlled Trial of a Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
- ClinicalTrials.gov ID
- NCT07516171
- Acronym / sponsor ID
- PrepDM / 26-01
- Conditions
- Labour Analgesia
- Keywords
- labour pain, education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Apr 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.
Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information.
The Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour.
This trial aims to evaluate whether directing patients to access to the website https://thepainlesspush.com/ improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website | Other | Other: Preparation for Decision Making (PrepDM) Scale, Other: QuestionnaireComparator: The Painless Push digital resource educates mothers about ways to manage pain during labour. |
| Mount Sinai Obstetric Anesthesia website | Other | Other: Preparation for Decision Making (PrepDM) Scale, Other: QuestionnaireControl group: website currently available to patients. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant individuals ≥ 18 years
- Visiting OB clinic at Mount Sinai hospital during their 3rd trimester of pregnancy (≥ 28 weeks gestation)
- Singleton gestation
- Nulliparous
- Considering labour epidural analgesia for childbirth
Key exclusion criteria (2 listed)
- Sensory, cognitive, or language barriers precluding participation
- Limited English proficiency
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 |
|---|---|---|
| Preparation for Decision Making (PrepDM) ScaleElectronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100. | Other | Mount Sinai Obstetric Anesthesia website, Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website |
| QuestionnaireElectronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale. | Other | Mount Sinai Obstetric Anesthesia website, Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website |
Primary outcome
Preparation for Decision Making (PrepDM) score
Time frame: Immediately following intervention (reading material)
PrepDM is a 10-item validated tool scored from 0 to 100. Higher scores reflect greater readiness for informed and shared decision-making
1 secondary outcome
Questionnaire - additional questions about digital material provided
Time frame: Immediately following intervention (reading material)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Ronald George, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparation for Decision Making (PrepDM) Scale and Questionnaire in people with Labour Analgesia, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 2 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: looking for participants now, 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald George, MD (416-586-4800 ext. 2681, ron.george@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparation for Decision Making (PrepDM) score (time frame: Immediately following intervention (reading material)). 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.