Should I Have an Elective Induction? The SELECTION Study
Phase: NA
Conditions: Labor, Induced, Patient Preference
Sponsor: University of South Florida

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Should I have an Elective Induction?   
The SELECTION study 
Aim 3 Pilot Trial 
 
Sponsored by: 
US National Institute of Health 
Grant #R21HD098496 
March 21, 2021 
 
Single Site IRB Approval:  
USF- Responsible IRB 
OSU- Relying IRB 
USF STUDY004944 
Initial approval 12/16/2022 
OSU site approval 2/14/23 
Modification #1 approved 3/10/23: Updates to study documents/questionnaires and 
remuneration plan prior to recruitment start 
Modification #2 approved 3/13/23: Correction to error in footer of consent prior to 
recruitment start 
Modification #3 approved 4/17/23: Modification to widen the gestational age for 
recruitment to 30-38 weeks gestation to accommodate obstetric appointment cadence. 
No change to study procedures.  
Modification #4 approved 5/16/23: Increase allowed consent/enrollment to up to 45 
participants per site in order to ensure 60 participants complete the initial study visit as 
planned  
 
Multiple Principal Investigators:  
Anjali Kaimal, MD, MAS (Contact PI) 
Professor and Vice Chair of Clinical Operations 
Department of Obstetrics and Gynecology 
University of South Florida Morsani College of Medicine 
 
Miriam Kuppermann, PhD, MPH 
Professor 
Department of Obstetrics, Gynecology & Reproductive Sciences 
School of Medicine 
University of California, San Francisco 
 
Co-Investigator: 
William Grobman, MD, MBA 
Professor and Vice Chair of Clinical Operations 
Department of Obstetrics and Gynecology 
The Ohio State College of Medicine 

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STUDY TEAM ROSTER 
University of South Florida 
Anjali Kaimal, MD, MAS 
PI/Contact PI 
akaimal@usf.edu  
Kaitlyn Tibbetts, MS 
Research Coordinator 
ktibbetts1@usf.edu  
Maha Al Jumaily 
Assistant Director of 
Research 
mahaaljumaily@usf.edu  
The Ohio State University 
William Grobman, MD, MBA 
Site PI/Co-investigator 
William.Grobman@osumc.edu  
Anna Bartholomew 
Clinical Research 
Manager 
Anna.Bartholomew@osumc.edu 
Taryn Summerfield 
Clinical Research 
Manager 
Taryn.Summerfield@osumc.edu  
Sophia Andreatta 
Research Coordinator 
Sophia.Andreatta@osumc.edu  
Melanie Paglione 
Research Coordinator 
Melanie.Paglione@osumc.edu  
University of California, San Francisco 
Miriam Kuppermann, PhD, 
MPH 
Principal Investigator 
Miriam.kuppermann@ucsf.edu  
 
 
 
 

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PERSONNEL AND DUTIES 
Contact Principal Investigator/Principal Investigator (PI) 
The PIs are experienced in all aspects of the design, conduct and oversight of 
randomized controlled trials and prospective studies at multiple clinical sites and is an 
expert in the fields of medical decision-making, decision-assisting tool creation and 
evaluation. The Contact PI will take a lead role in all aspects of the proposed project, 
working with the Pi and site PI and staff members to ensure timely and accurate 
completion of the project. The Contact PI will direct day-to-day activities and provide 
overall governance and scientific leadership to the study. 
Site Principal Investigator (site PI) 
The site PI will meet as needed to contribute to the overall study design and ensure 
each site is executing the study as prescribed. The Site PI is responsible for hiring and 
training site staff and will provide clinical and research expertise in the design and 
implementation of study instruments and protocols. The Site PI will monitor study 
enrollment and troubleshoot any recruitment issues as needed. They will also assist 
with chart review for participant delivery outcomes as needed.  
Research Coordinators/Managers 
The Research Managers and Coordinators (RCs) are the primary administrative points of 
contact for the study. They will prepare and submit all materials for IRB approval 
including the initial application, renewals, and all modifications. They will pilot and fine-
tune study instruments; screen, consent, and interview participants; abstract medical 
data from charts; and distribute participant remuneration. They will be responsible for 
following the guidelines for study operations outlined in this protocol and will email the 
Contact PI in the event of any protocol violations (e.g., erroneous inclusion of subjects in 
the study, breach of confidentiality). They will participate in conference calls as needed 
to go over recruitment and data collection activities and targets.  
 
 

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1.0 Study Summary  
 
Study Title 
Should I have an Elective Induction?  The SELECTION Study 
Study Design 
Single arm pilot study of feasibility and acceptability of a 
decision support tool (DST) for elective induction of labor 
(IOL).  
Primary 
Objective/Purpose 
The goal of the proposed study is to perform a pilot test of 
a patient-centered DST to help women and providers work 
together in making informed, shared decisions regarding 
whether or not to opt for elective IOL at 39 weeks 
gestation   
Secondary 
Objective(s)/Purposes 
This study will provide the information needed to plan a 
randomized trial of the DST for support of the equitable 
offer of induction of labor.   
Research 
Intervention(s)  
Exposure to the decision support tool 
ClinicalTrials.gov NCT # 
NCT05838313 
Study Population 
Nulliparous people with singleton, vertex pregnancies at 
36-38 weeks who are planning vaginal delivery and do not 
have a medical indication for induction of labor 
Sample Size 
60  
Study Duration for 
individual subjects 
Approximately 2 months  
Study Specific 
Abbreviations/ 
Definitions  
DST: decision support tool 
IOL: induction of labor  
CD: cesarean delivery 
 
 
 

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2.0 Background and Objective  
The ARRIVE trial, a large multicenter study published in 2018, compared expectant 
management to induction of labor at 39 weeks absent medical indication and found that 
induction was associated with a decrease in CDs, preeclampsia/gestational hypertension, as 
well as in the need for neonatal respiratory support, without a statistically significant difference 
in adverse perinatal outcomes. Subsequently, both the American College of Obstetricians and 
Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) issued statements 
that it was reasonable to offer elective induction of labor to low risk, nulliparous pregnant 
people (the population studied in the trial and the population who will be eligible for the 
current study). A study based on birth certificate data published in 2022 showed that the offer 
of elective induction of labor has been integrated into clinical practice.  However, how, when, 
and to whom this option is offered is unclear. While the improvement in maternal and neonatal 
outcomes observed in this trial are compelling, little is known about how patients and providers 
view the routine offer of elective IOL at 39 weeks, which is a significant change in practice. 
Ultimately, the goal of this study is to support the equitable offer of elective induction of labor 
to all eligible people, and to support pregnant people in making an informed choice that is 
concordant with their values. 
Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for 
nearly one third of births annually. Reducing the CD rate has been targeted as an important 
public health goal; however, achieving this goal has proven challenging. In parallel, delivery at 
39 weeks has been suggested as optimal for the neonate, but controversy about the 
relationship between induction of labor (IOL) and CD has limited enthusiasm for utilizing IOL as 
a means of achieving delivery at this gestational age. Finally, the appropriateness of the 
intervening in pregnancy without a clear medical indication is highly controversial. Given the 
current professional American College of Obstetricians and Gynecologists (ACOG) guidance 
that: “Based on the findings demonstrated in this trial (ARRIVE), it is reasonable for 
obstetricians and health-care facilities to offer elective induction of labor to low-risk nulliparous 
women at 39 weeks gestation.”, potential complexity of discussions about elective IOL at 39 
weeks and the significant population of women who likely will be presented with this option, a 
decision support tool (DST) may help to improve the efficiency of shared decision making and 
ensure incorporation of informed patient preferences around this offer. The goal of the 
proposed study to conduct a pilot study of the impact, feasibility, and acceptability of a 
prototype decision support tool for elective induction of labor.  
 
3.0 Study Design and Hypotheses 
This is a single arm prospective clinical trial to collect pilot data for planning a future 
study of the impact of the Elective IOL DST, the intervention of interest, on induction rates, 
cesarean delivery rates, decision quality and resource use.  The primary goal of this pilot is to 
determine the acceptability of the Elective IOL DST, to assess the feasibility of recruiting and 
retaining study participants in anticipation of future effectiveness and implementation studies, 
and to finalize outcome and other measures. The descriptive analyses planned include cross-
sectional analyses, which will consist of profiles of the sample, including examination of means 
and proportions, measures of variability, and confidence intervals around these statistics. We 
also will investigate relationships within and between measurement domains (e.g. 

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demographics, outcomes), although these will only be exploratory in nature.  In addition, we 
will describe the trajectories of participant responses across time.   
 
As a pilot study, there are no hypotheses to be tested; therefore formal sample size calculations 
are not appropriate.   
 
4.0 Study Intervention  
The Elective Induction of labor decision support tool is viewed on a tablet, phone, or 
computer.  It includes information regarding induction of labor, the potential benefits and risks 
of induction and expectant management, as well as values clarification questions to help people 
to think through what matters most to people as they consider their decision.  In this single arm 
pilot trial, all participants will view the decision support tool. 
The current project is the third part of a three-part study funded by the NIH.  The overall 
goal of the project is to develop a patient-centered decision support tool to help women and 
providers work together in making informed, shared, values concordant decisions regarding 
whether or not to opt for elective IOL at 39 weeks gestation.  
We have continued to improve upon the process that our group has used to develop 
other patient-centered prenatal care-related DSTs, which have been tested in NIH-funded, 
multicenter, randomized clinical trials among English- or Spanish-speaking pregnant women 
(R01HD078748, R01HD04968). The design process we have used to develop our DSTs follows 
the standards put forward by the International Patient Decision Aids Standards (IPDAS) 
Collaboration, using a systematic development process based on the IPDAS quality checklist.  
We utilize a patient-centered approach, which always begins by examining the needs, desires, 
and behaviors of the target population. We rely on published, validated literature for the 
information included in the decision support tools and utilize an iterative process to obtain 
input from patients and health care providers regarding their views on informational and 
decision-support needs. Using this patient-centered design approach, our designers work with 
researchers, providers, and patients to leverage the expertise of all parties in ways that exceed 
standard expectations for the engagement of these parties in research. This approach allows us 
to better connect with the people who are the center of our research, and enables quick and 
effective transformation of data into actionable ideas/tools. 
In developing this tool, we began by conducting formative research to gain an 
understanding of how women and providers view the potential offer of elective induction of 
labor at 39 weeks gestation. We interviewed pregnant and postpartum women, to determine 
what they know and feel about elective IOL at 39 weeks and how they would view being 
presented with a choice between this intervention versus expectant management. We also 
interviewed providers (obstetricians, midwives, prenatal nurses and labor and delivery nurses) 
to obtain their thoughts on elective IOL at 39 weeks, how they view the latest data on its role, 
and how comfortable they would feel offering this option to their patients.  We transcribed and 
coded these interviews and continued interviews until thematic saturation was reached.  Based 
on our findings and the published literature and professional guidance regarding elective 
induction of labor, we created the prototype patient-centered DST.  The DST begins with the 
statement “Your health care providers can tell you a lot about these two approaches and the 
advantages of each, but YOU are the expert about what is important to you” and aims to 

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present balanced information to support the user in making an informed, values concordant 
choice between the two options. It presents information on elective IOL at 39 weeks versus 
expectant management, including information regarding the processes and potential outcomes 
of each approach to delivery, and incorporating values clarification exercises as well as a 
summary statement that women can use in discussing this option with their providers. We then 
pretested the tool in pregnant and postpartum women and reviewed it with providers to obtain 
their feedback on the content and presentation, iteratively using that process to improve the 
prototype. 
 
4.0 Study Population 
Inclusion and Exclusion Criteria 
This study will include 60 pregnant people at two sites. Eligibility criteria will include nulliparity, 
singleton pregnancy, no contraindication to vaginal delivery, no medical indication for IOL, age 
18 years or older and an ability to speak English (as study materials are only available in English 
at this time). Exclusion criteria will include people not planning a vaginal delivery, eople who 
have had a baby in the past, people with a medical indication for induction of labor at the time 
of enrollment, people younger than 18 
Participant Withdrawal 
People who experience a pregnancy loss (stillbirth) will not be contacted for any additional 
study visits.  This is expected to be an extremely rare event in this low risk population.  People 
may also request to be withdrawn from the study if they no longer want to participate. 
 
5.0 Recruitment 
Each site will utilize the same recruitment methods that we have used successfully in prior 
studies of pregnant people. We will ensure that all necessary human subjects’ reviews and 
approvals are obtained prior to implementation at any recruitment site.   
 
Potentially eligible participants will be identified by reviewing outpatient charts to identify 
pregnant people who meet the eligibility criteria. At all sites, both academic and “private” 
practices are associated with an academic health system, and as such, with IRB approval, study 
staff is able to remain HIPAA-compliant when they pre-screen patients. 
 
At USF, eligible people will receive a letter describing the study, signed by a leadership 
representative of their OB practice (as many patients do not have a single provider they see for 
prenatal care, but rather see a team of providers).  A stamped return “opt in/out” card will be 
included, which the recipients can return to indicate that they are either interested or not 
interested in hearing from the study staff. The site-specific interviewer’s telephone number also 
will be included for each recipient’s use if they prefer to use this method of communication. 
Respondents who check “opt in” will be called/contacted by the method they state they prefer.  
Those who opt out will not be contacted.  A study staff member will come to a subsequent visit 
at which time the clinical staff will ask the participant if they would be willing to discuss the 
study and assess their eligibility and interest in participating. The “opt out” mechanism has 
been shown to yield a more diverse group of participants than the “opt in” approach, and, in 
our many studies of diverse populations, has been highly effective in recruiting participants for 

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studies that require conducting face-to-face interviews with pregnant people at specific 
gestational ages.   
 
At OSU, eligible people will receive a brochure detailing the study.  Those who are eligible and 
interested will be contacted to set up an enrollment interview.  
 
Participants will be identified starting at 32-34 weeks with the goal of scheduling the initial 
study visit between 36+0 and 38+0 weeks gestation to allow time to view and consider the 
information in the decision tool prior to making a decision regarding whether to proceed with 
an elective induction at 39+0 to 39+6 weeks gestation. 
 
5.0 Study Procedures 
The procedures and/or interventions conducted as part of this research are low risk, 
educational interventions.  Elective induction, or induction of labor absent medical indication is 
an evidence-based aspect of routine pregnancy care that has been endorsed by the OBGYN 
professional society guidelines as being reasonable to offer since 2018. In clinical practice, the 
way that this option is offered is currently highly variable and driven by the provider rather than 
by the patient’s preferences and goals. The intervention in this study will be the viewing of 
standardized information about elective induction of labor prior to making their decision about 
this option with their provider.  Questionnaires will be utilized to understand the impact of the 
educational intervention on decision quality and the feasibility and acceptability of the 
intervention. 
We will prospectively enroll 60 nulliparous people (approximately 30 at USF and 30 at 
the Ohio State University) planning vaginal delivery with singleton, vertex pregnancies at 36-38 
weeks who do not have a medical indication for IOL to view the DST. During their enrollment 
face-to-face interview, they will review the DST and complete pre- and post-DST viewing 
questionnaires.  We will conduct telephone interviews a few days later but before 39+0 weeks, 
and again 2-4 weeks postpartum.  During these interviews, we will collect information on the 
acceptability of the tool and decision quality. We also will include an open-ended question in 
the postpartum interview to obtain feedback on topics and information the participants wish 
had been included in the DST.   
At the time of enrollment, written informed consent will be obtained by the study 
research coordinator. The consent form will include information about the purpose of the 
study, the nature of the subject’s participation, the possible risks and discomforts associated 
with participation, the potential benefits of participation, a statement of the voluntary nature 
of participation, and a description of the mechanisms used to ensure confidentiality. A study 
eligibility checklist will be completed prior to any study procedures. Parental consent will be 
obtained to review the medical records of the infants.  Assent is not appropriate given the 
clinical scenario (review of infant medical records). 
• Participation will consist of one face-to-face enrollment interview and two follow-up 
telephone interviews, along with permission to access the patient’s medical chart. 
Patient-reported data will be collected at 4 time points: at the beginning of the 
enrollment interview, prior to DST viewing (T1); at the conclusion of that interview, post 
DST viewing (T2); during a telephone interview at 38-39 weeks gestation, by which time 

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the decision to undergo or forego elective IOL at 39 weeks will have – or will be close to 
having been made (T3); and during second telephone interview 2-4 weeks postpartum 
(T4). 
• Participants will initially view the DST on a tablet during the enrollment interview.  At 
the conclusion of the interview, they will be provided with a unique link so that they can 
revisit the DST content from their personal phone, tablet, or computer if desired. 
• During the enrollment interview (T1), we will administer a sociodemographic 
questionnaire and assess the participant’s health literacy level using the Newest Vital 
Sign (NVS) measure.  We also will ask a series of questions related to her inclination to 
undergo elective IOL at 39 weeks, her attitudes and beliefs about this intervention, her 
desire for shared decision making in this context, and her feedback regarding the 
decision tool.  
• Attitudes and beliefs (T1, T2, and T3) will be assessed by presenting a series of 
statements for which participants will be asked to indicate the extent to which they 
agree or disagree. To measure decisional conflict (T2 and T3), we will use O'Connor's 
Decisional Conflict Scale, a measure that assesses patients' uncertainty in making a 
health-related decision, factors that contribute to this uncertainty; and whether they 
feel their decision making was effective).  To measure DST satisfaction (T2, T3, and 2-4 
weeks postpartum (T4)), we will use an adapted version of a 3-item intervention-
satisfaction scale that we have previously used based on a measure developed by Barry 
et al. We will use the SDM-9 to measure shared decision making (T3 and T4). During T4, 
we also will administer the 6-item Birth Satisfaction Scale-Revised Indicator (BSS-RI), 
which measures stress and emotional response to labor and birth, as well as the Labor 
Agentry Scale, which measures expectations and experiences of personal control during 
childbirth and was one of the outcomes measured in the ARRIVE trial.  We will include 
an open-ended question asking what else, if anything, the pregnant person would have 
wanted to know at the time she made her decision. Outcomes obtained via chart review 
after delivery will include uptake of elective IOL at 39 weeks, delivery mode undergone 
(vaginal or cesarean), hospital length of stay (prior to and after delivery), and clinical 
outcomes (gestational age at delivery, preeclampsia, gestational hypertension, and 
maternal and neonatal outcomes).  
• During the initial face-to-face visit, we will ask participants their preferences for 
scheduling phone follow up interviews so we can streamline the process as much as 
possible.  Follow up questionnaires can be completed independently via RedCap survey 
T1: Prior to DST viewing 
T2: Post DST viewing 
T3: 38-39 weeks gestation 
T4:2-4 weeks postpartum 
• Sociodemographics, 
health literacy 
• IOL inclination 
• IOL attitudes  
• Desire for shared decision 
making 
• Provider preferences and 
social norms 
• IOL inclination 
• IOL attitudes  
• Decisional conflict 
• DST impact and 
satisfaction 
• IOL inclination 
• IOL attitudes  
• Desire for shared decision making 
• Provider preferences and social 
norms 
• Decisional conflict 
• Shared decision making 
• DST impact and satisfaction 
• Shared decision making 
• DST impact and 
satisfaction  
• Birth Satisfaction Scale 
• Labor Agentry Scale 
• Things you wish you had 
known (open ended) 

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link; an appointment will be scheduled so that the participants can ask questions if 
needed.  Clinical outcomes will be obtained via chart review after delivery. 
• Subject Costs and Compensation: The face-to-face interview will take approximately one 
hour (participants will be remunerated with $40); telephone interviews will take 15 
minutes ($20 each). 
 
6.0 Risks and Protections against Risks 
Risks or discomforts for the pregnant people are limited to those that might be incurred 
as a result of discussing sensitive or potentially troubling information as well as potential risks 
to confidentiality.  
Some of the questions addressed by the proposed study are of a sensitive nature and 
require the subject to consider outcomes that they may find distressing (e.g., pregnancy 
complications).  It is possible that these topics may induce anxiety among respondents.  While 
this has not been a problem in our prior studies of potentially anxiety-provoking decision tools 
(including tools used by pregnant women that discuss the possibility that their fetus may be 
affected by a serious disorder or that they will experience a pregnancy loss and be unable to 
give birth in the future) it is important that we carefully consider how we will minimize the 
likelihood of this problem and how we will assist our participants if their participation does 
result in some anxiety. 
First, all participants will be informed, prior to participation, that they are free to 
terminate their participation at any time or to decline to answer any questions or participate in 
any part of the study.  During the consent process, we will ensure that the participant 
understands this principle and they feel free to exercise their option at any time.  Participants 
will have access to their obstetric providers to discuss their concerns as well as to the clinician 
investigators at each site.   
Additionally, participants will be informed that if they develop any feelings of anxiety at 
any time during their participation, they should contact the study team (they will be provided 
with an access number).  These participants will be contacted within 24 hours by one of the 
study clinician-investigators.  All of these clinicians have extensive clinical experience and are 
highly skilled in dealing with patients who develop anxiety during their medical care.  They are 
available at any time via their hospital on call system.  The responding physician will contact the 
participant and discuss their clinical situation.  If necessary, the physician will meet with the 
participant in person at their clinical office or the office of the participant’s primary obstetric 
provider (wherever the participant feels most comfortable).   
If a participant's symptoms require more intensive intervention, this will be arranged by 
the clinician-investigator to ensure that the participant will receive all necessary care to address 
whatever symptoms might occur.  The physician-investigator who becomes involved with any 
participant over any anxiety symptoms will continue to monitor the patient (either by phone or 
in person) until all symptoms have abated.   
Each contact will be reported and tracked as an adverse outcome.  
In sum, we have an extensive support infrastructure for the management of mental 
health issues that arise in the course of study participation.  As noted, we have conducted 
similar studies in the past and have not had problems with anxiety, but we are fully prepared to 
deal with this possibility at any time should it occur.  

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Undue influence will be minimized by emphasizing the voluntary nature of the study in 
all recruitment materials and personal communications.  Participants also have the alternative 
not to participate in the study. Non-participation will not affect clinical care.  Participants will be 
consistently reminded that responses to any queries deemed sensitive or uncomfortable (e.g. 
country of origin/ immigration status, income, previous history of abortion) should be 
considered optional, and they may decline to answer any question(s) and can refuse to 
continue the study at any point.  Participants also will be reassured that neither their 
opportunities for continued health care nor their relationships with health care providers will 
be jeopardized by study participation. 
 
7.0 Data Management and Confidentiality 
We will take extensive precautions to maintain participant confidentiality throughout 
the study. First, lists of individuals who will be participating will be kept in a locked drawer and 
in password protected computer files in the office of the study coordinator at each site.  Used 
consent forms will also be locked in a filing cabinet in the office of the study coordinator.  
Confidentiality of all study-related records will be maintained in accordance with State and 
Federal laws. 
Three databases will be maintained for the study: 1 and 2) Site specific “participant 
tracking” databases will contain all identifying information that will permit locating participants 
for their interviews, ensuring that interviews are completed on time, and performing chart 
reviews. It will include demographic information for all patients who do not meet the eligibility 
criteria or who decline participation, along with their reasons for refusal (to permit comparisons 
between those who do and do not enter the study). 2) A single“study data” database will 
contain all project-related data used for the analyses. Participants will be identified only by a 
code number in the study database. 
Obstetric clinic schedules will be reviewed to screen for eligibility, so that only subjects 
meeting eligibility criteria will be approached.  We will keep the minimum information 
necessary (Name, MR#, appointment date and time) in the recruitment database so that we 
know who has an appointment and can make sure recruitment materials are available when 
they are in clinic.  People who decline will be marked as declining so that they are not 
approached again. Records reviewed will only be from people who are actively receiving 
prenatal care and scheduled for appointments within the 4 weeks prior to the timeline for the 
study.  Only study staff will have access to the RedCap database.  Because we can only identify 
eligible patients based on medical record review, it is not practical to obtain consent prior to 
the approach.  Identifiers will be removed within 6 months and only information needed to 
inform the CONSORT diagram will be maintained. 
Only the PI and a limited number of study personnel will have access to identified 
information which will be encrypted and stored on a secure server. As in our previous studies, 
only code numbers will be used and no individual identities will be retained in the analysis or 
publications. Data confidentiality will be ensured by using only a coded participant acrostic and 
code number to identify respondents on the data-collection forms. All data will be entered into 
RedCap database that will have logic, range, and error checking, and will be kept on an 
encrypted, security enabled network. Only researchers involved with the study will have full 
access to subject identities. Datasets used for analysis will be de-identified.  As per the USF 

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guidelines, records will be maintained for 5 years after the study is complete and at that time 
we will destroy records linking participants’ names to study ID numbers.  Participant identities 
will not be revealed in any publication that may result from the proposed study.   
 
8.0 Potential Benefits to Subjects or Others 
There is no definitive direct benefit to people participating in the study.  However, we 
anticipate that the results we obtain will result in an elective induction DST that can be testing 
in a future study.  In the future, this tool has the potential to enable pregnant women and their 
obstetric providers to engage in joint decision making buttressed by an evidence-based 
approach and to decrease the rate of cesarean delivery and maternal hypertensive 
complications of pregnancy in this country, without a negative impact on neonatal outcome.  
We believe that these potential benefits outweigh the minimal risks mentioned above. 
 
Importance of the knowledge to be gained This study will evaluate an innovative decision 
support tool for women who are considering whether or not to proceed with elective induction.  
This tool will help women consider their preferences in the context their likelihood of vaginal 
delivery, along with the chances of other potential outcomes of this decision.  If it is shown to 
have a positive impact on decision quality, we believe that the use of this tool would result in a 
more individualized, patient-centered approach to this emerging decision in obstetrics, 
resulting in improved decision quality, quality of care, concordance between patient and 
provider expectations, and health outcomes, including a reduction in the cesarean delivery rate 
and improvements in maternal and neonatal outcomes.  
 
9.0 IRB approval, safety monitoring and adverse event reporting 
IRB Approval 
This is a single site IRB study; USF is the responsible IRB and there is a reliance agreement in 
place with OSU.  The overall consent form as well as the OSU site specific addendum as well as 
all of the study materials have been reviewed as per the single site IRB protocol.  Amendments 
or modifications will be reviewed by the USF IRB in accordance with the reliance agreement. 
 
The Contact PI or RC will provide safety and progress reports to the IRBs at least annually and 
within three months of study termination or completion. These reports will include the total 
number of participants enrolled in the study, the number of participants who completed the 
study, all changes in the research activity, and all unanticipated problems involving risks to 
human subjects or others.  
 
Informed Consent: Written informed consent will be obtained from each study participant prior 
to enrollment using an approved informed consent form in accordance with all applicable 
regulations. A copy of her signed informed consent form will be offered to the participant. 
 
Safety Monitoring and Clinical Data Review 
Research coordinators will report all participant complaints to the investigative team.  These 
will be discussed during research team and investigator calls. 

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Each study site is responsible for continuous close monitoring and management of adverse 
events (AE) in accordance with the protocol for AE reporting. The study site PIs are responsible 
for the initial evaluation and reporting of safety information and for alerting the investigative 
team if unexpected concerns arise.  
 
Reporting Requirements for this Study 
The site PI or RC will report an adverse event to the local IRB and responsible IRB if study staff 
determines it may qualify as an Unanticipated Problem or Adverse Event because the event 
meets all three criteria listed below: 
• Unanticipated in severity or frequency  AND 
• At least possibly related to the study intervention AND   
• Is Serious OR not serious but suggests placing subjects or others at greater risk 
In addition, all SAEs will be reported to the study team within 72 hours of recognition by study 
staff. 
 
Use of Information and Publications: A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov. Presentation and publication of the results of this study will be 
governed by guidelines determined by the study team and as necessary and appropriate by 
their associated institutions policies. Any presentation, abstract, or manuscript will be approved 
by the PIs prior to submission.  
 
10.0 Analysis Plan 
Statistical Design and Power 
As a pilot study, there are no hypotheses to be tested; therefore formal sample size calculations 
are not appropriate. 
 
This is a single arm prospective clinical trial to collect pilot data for planning a future study of 
the impact of the Elective IOL DST, the intervention of interest, on induction rates, cesarean 
delivery rates, decision quality and resource use. The primary goal of this pilot is to determine 
the acceptability of the Elective IOL DST, to assess the feasibility of recruiting and retaining 
study participants in anticipation of future effectiveness and implementation studies, and to 
finalize outcome and other measures. The descriptive analyses planned include cross-sectional 
analyses, which will consist of profiles of the sample, including examination of means and 
proportions, measures of variability, and confidence intervals around these statistics. We also 
will investigate relationships within and between measurement domains (e.g. demographics, 
outcomes), although these will only be exploratory in nature. In addition, we will describe the 
trajectories of participant responses across time.