Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injuries, Pregnancy Related
Sponsor: University of Michigan

 
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Pilot Testing a New Pregnancy Decision Making Tool for Women with Spinal Cord 
Injury 
 
NCT04872569 
 
April 29, 2021 
 
 
 
 

 
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INTRODUCTION 
The decision to pursue pregnancy for many women with spinal cord injury (SCI) is too often made in a vacuum of 
knowledge, with limited guidance from clinicians, and in many cases, in the face of bias and discrimination. 
Literature suggests that knowledge about SCI and pregnancy is poorly disseminated to women1 with many 
receiving inadequate information before becoming pregnant.2 Uncertainty and anxiety about pregnancy is not 
uncommon for women with SCI2,3 with the injury heavily influencing their decisions about pregnancy.4 Their 
uncertainty is further compounded by difficulty finding clinicians with joint expertise in SCI, gynecology and 
obstetrics and the need for better care coordination during pregnancy.1 Despite the importance of motherhood 
to many women with SCI, up-to-date educational and other materials to support pregnancy planning is 
extremely limited.5  
Clinicians face their own ambivalence and uncertainty with limited knowledge of disability6 and SCI7,8 and 
training9 to provide high quality care to women with SCI. This is compounded by a lack of clinical guidelines10 to 
inform care. The ambivalence many clinicians have in providing care to women with SCI reflects broader societal 
expectations that women with disabilities are asexual and that pregnancy is highly improbable.11,12 
Unfortunately, this enduring stigma continues to influence the experience of many women seeking counsel 
about pregnancy.13 Such longstanding myths, compounded by attitudinal and environmental barriers, have 
resulted in ill-informed and inadequate healthcare that is dramatically out of step with the hopes of women with 
SCI wishing to become mothers.  
There is mounting and robust evidence that decision-making tools improve the quality of decisions and the 
decision-making process.14 International standards to guide the development process15 ensure rigor and 
relevance in their design. The purpose of this study is to test the efficacy and acceptability of a new pregnancy 
decision-making tool designed for women with SCI to support the decision-making process.  
METHODS 
Sample Characteristics – Women will have a traumatic or non-traumatic cause of SCI and at least 18 years old; 
aim-specific criteria are given below. Three items from the Behavioral Risk Factors Surveillance System16 will 
determine disability severity based on the need for assistance with daily life activities and/or personal care; 
women with mild, moderate or severe severity will be eligible. Women who are eligible will be actively planning 
or in the process of making a decision about whether or not to get pregnant in the near future. The language is 
deliberately open based on feedback from women during development. The decision-making process for many 
women with SCI can be protracted given many uncertainties and a general lack of information and health care 
provider expertise. 
Description of the Decision Making Tool – The decision making tool is a web-based site with a set of 9 
downloadable worksheets (uploaded in Section 12, Exemption 3, #8 of the application). We developed the tool 
through iterative brainstorming sessions with stakeholders and used a survey, focus group, and interview data 
from women with SCI who have been pregnant, decided not to get pregnant, or are considering a future 
pregnancy. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy and 
reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.17 This 
framework targets determinants of decisions that may be potentially modifiable by a decision-making tool, but 
are currently suboptimal for patients and health care providers due to factors such as inadequate knowledge, 
high uncertainty, or biased perceptions of others.  
• 
Overview of Pregnancy – Reviews changes in a woman’s body during pregnancy. This is not meant to be 
exhaustive but a general overview. 

 
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• 
Knowing what is important to you – Reflects Ottawa Framework’s values component. Worksheet focuses on 
what is important to the woman as a foundation for decision making. It has several options to answer 
questions about values and learn more about how other women with disabilities answered the same 
question (links out to a summary report).  
• 
Partners, family and important relationships – Reflects Ottawa Framework’s support component. Guides the 
woman in talking about her decision and engaging those most important to her. The worksheet supports 
conversations that can be challenging to have.   
• 
Physical function and independence – Reviews major domains of physical function and the possible effects 
of pregnancy on the woman’s independence. The worksheet highlights topic areas to discuss with different 
health care providers. 
• 
Health and wellbeing – Provides an overview of the different medical specialties that might be involved in 
care during planning and during a pregnancy and reviews major areas of mental and physical health that 
could be affected during pregnancy. The worksheet presents a series of questions a woman can review with 
her family and health care providers. 
• 
Caring for an infant – Encourages women to consider various aspects of caring for an infant that may apply 
to them. The worksheet provides a list of considerations to support further dialog with her family and health 
care providers. 
• 
SCI after pregnancy – Addresses possible changes after pregnancy, such as regaining physical fitness, to 
consider in decision-making.  
• 
Financial resources & insurance – Addresses the need for financial planning in anticipation of a pregnancy 
and childcare. The worksheet reviews various aspects of planning a woman should consider as part of her 
decision making.  
• 
How to find reliable information and resources – Provides guidance for how to find information and judge its 
quality. The worksheet provides a step by step guide for evaluating online resources.  
• 
Connecting with other women with SCI – General guidance for connecting to their peers. 
• 
Dealing with reactions of others, stigma and bias, pressure – Addresses the pressures women with 
disabilities can face during decision making about pregnancy.  
• 
Reaching a decision – A closing section that highlights that it is OK to be wherever the woman is in the 
process, the different ways she may feel, and that it’s OK to take a break if needed.  
Intervention Delivery, Feasibility and Efficacy Testing – We will provide the tool for a 3-month trial to 40 women 
with SCI, allowing each woman to use the tool at her own pace. A pre-post design was selected following the 
recommendations of O’Connor and Jacobsen18 for pilot testing new decision-making tools; this will help us 
prepare the tool for the next phase of testing that will utilize a parallel groups design. Similarly, the sample size 
was based on feasibility at this stage of the tool’s development. We will assess outcomes at baseline, 6 weeks 
and the end of the trial period. For pilot testing at this stage of the tool’s development, we are interested in 
several dimensions of feasibility and preliminary support for its efficacy. Using Bowen et al.’s19 phases of 
intervention development, we are primarily concerned with assessing “can it work”.  Participants will be 
compensated $40 for their time. 

 
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Recruitment – Three methods will be utilized to recruit pilot participants: (1) study announcement published in 
our project newsletter requesting that interested women contact us, (2) social media postings on our project 
webpage and with groups we have connected with in the past, and (3) study announcement posted on UM 
Health Research. It is possible that women who participated in the earlier development work for this project, 
under HUM00149452, will choose to participate in this pilot study. Data generated under HUM00149452 will 
not be linked to data from this study. 
Outcome Assessment – In pilot testing the new tool, we are interested in feasibility and preliminary 
effectiveness. Specifically, we are interested in the tool’s acceptability, demand for it, and its implementation (or 
use of the tool). For preliminary efficacy, the goal for pilot testing is not for a woman to make a decision about 
pregnancy during the intervention period. Rather, assessment will focus on three domains of interest we expect 
to be influenced positively by the use of the tool.  
We will also ask a sub-set of women if they would be interested in an opened ended interview to learn more 
about their experience using the tool and any other feedback they wish to share. This is not required and is not 
highly structured; it will be an informal conversation for those wishing to share more in depth feedback. 
• 
Decisional conflict is characterized by uncertainty about a decision. The Decisional Conflict Scale20 is a widely 
used outcome measure of decision-making with strong support for its validity.20-22 We will use the 
uncertainty sub-scale for decisional conflict, the support subscale for having the support of others, and the 
values subscale for clarity of values.  
• 
Decision or choice predisposition will be assessed using the single-item Stage of Decision-Making Scale.23 
The scale ranges from “haven’t begun to think about choices” to “have already made a decision and unlikely 
to change my mind” but are modified to fit pregnancy and excludes the option of not having begun to think 
about choices since we are only including women actively planning or considering a future pregnancy. 
Outcomes, measures, and time when collected are summarized in the table. Outcome measure items are 
presented on pages 6-8. All measures will be completed via online survey, or by telephone if requested by the 
participant. 
Dimension of 
feasibility 
 
Evaluates 
Study-Specific 
Outcomes 
Measures 
When  
Collected (Baseline, 6 
weeks, 12 weeks) 
Acceptability 
How participants 
react to the 
intervention 
Satisfaction with tool; 
usefulness of the tool; 
intent to keep using the 
tool 
Likert scales of overall 
satisfaction, usefulness; ratings 
of the presentation and balance 
of information.  
12 weeks 
Demand 
How much the 
intervention is likely 
to be used 
Frequency of actual use 
of the tool, interest in 
using the tool 
Actual use (dates, duration) and 
interest in continuing to use the 
tool 
Demand item: 6 and 12 
weeks. 
Web Analytics: 
throughout 
Implementation 
How can the tool be 
delivered 
successfully 
Factors affecting the use 
of the tool, ease or 
difficulty of using the tool 
Likert scales of barriers and 
facilitators of tool use 
12 weeks 
Preliminary 
efficacy 
Does the tool show 
promise of being 
successful with the 
intended population  
Less decisional conflict; 
support of others; more 
clarity of values; greater 
readiness to make a 
Decisional Conflict Scale sub-
scales; Stage of Decision-Making 
Scale. 
Baseline, 6 and 12 weeks 

 
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decision (stage of decision 
making) 
Screening, Demographic and Background Variables – The list of screening, demographic and background 
variables are uploaded in the application, Section 12, Exemption 3, #8. These data will be collected at time of 
screening by phone; demographic and background variables will be collected post consent. 
Analysis – Descriptive statistics will be used to summarize single item Likert scales. To examine preliminary 
efficacy of the tool, statistical analysis will include within-subjects, repeated measures analytic approaches (i.e., 
linear mixed models) to test the direction and magnitude of change on efficacy outcomes. Models will include 
selected disability characteristics (e.g., congenital vs. acquired) to test if the tool performs similarly across 
disability types. 
 
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