N/A
N=23
Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)
Spinal Cord Injuries · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT04872569 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Final Decisional Conflict Scale Score - Values Clarity Sub-scale — 13.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision-making tool (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Michigan
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Decisional Conflict Scale Score - Values Clarity Sub-scale |
13.4 | — |
| PRIMARY Final Decisional Conflict Scale Score - Support Sub-scale |
13.1 | — |
| PRIMARY Final Decisional Conflict Scale Score - Uncertainty Sub-scale |
11.8 | — |
| PRIMARY Final Readiness to Make a Choice in Stage of Decision-Making Scale |
3.19 | — |
| SECONDARY Feasibility - Acceptability |
38.96 | — |
| SECONDARY Feasibility - Demand |
3.43 | — |
| SECONDARY Feasibility - Ease of Use |
4.4 | — |
Summary
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Eligibility Criteria
Inclusion Criteria
- Spinal cord injury (traumatic or non-traumatic)
- Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible
- actively planning or in the process of making a decision about whether or not to get pregnant in the near future
Exclusion Criteria
- No plans for getting pregnant
Data sourced from ClinicalTrials.gov (NCT04872569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.