NCT07516171

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 17, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 31, 2026

Last Update Submit

April 14, 2026

Conditions

Labour Analgesia

Keywords

labour paineducation

Outcome Measures

Primary Outcomes (1)

  • 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

    Immediately following intervention (reading material)

Secondary Outcomes (1)

  • Questionnaire - additional questions about digital material provided

    Immediately following intervention (reading material)

Study Arms (2)

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.

Other: Preparation for Decision Making (PrepDM) ScaleOther: Questionnaire

Mount Sinai Obstetric Anesthesia website

OTHER

Control group: website currently available to patients.

Other: Preparation for Decision Making (PrepDM) ScaleOther: Questionnaire

Interventions

QuestionnaireOTHER

Electronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale.

Mount Sinai Obstetric Anesthesia websiteSociety for Obstetric Anesthesia and Perinatology (SOAP) Painless push website
Preparation for Decision Making (PrepDM) ScaleOTHER

Electronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100.

Mount Sinai Obstetric Anesthesia websiteSociety for Obstetric Anesthesia and Perinatology (SOAP) Painless push website

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Sensory, cognitive, or language barriers precluding participation
  • Limited English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Weights and MeasuresSurveys and Questionnaires

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ronald George, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald George, MD

CONTACT

416-586-4800ron.george@uhn.ca

Kristi Downey, MSc

CONTACT

416-586-4800kristi.downey@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)