Clinical trial NCT03202550
Conditions: Oral Sedation and Cervical Dilator Pain
Keywords: Oral Sedation Lorazepam Oxycodone
Sponsor: Johns Hopkins University
Start date: 2017-06-28; Completion date: 2019-05-28
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, double-blind, placebo-controlled trial involving 2 arms. It will be comparing the effects of placebo compared to 1 mg oral lorazepam/5 mg oral oxycodone on pain scores during cervical dilator placement prior to dilation and evacuation (D\&E).

Detailed description:
Potential participants will be first introduced to the study via routine intake call. Participants will be identified at the participant's office visits to the Johns Hopkins' Women's Center for Family Planning. If a patient desires D\&E for a second trimester pregnancy, the patient will first receive standard counseling. Only after providing written informed consent for the procedure will the patients be screened for eligibility in the study. If the patient is eligible the participant will be asked by a member of the research team if the patient is interested in participating. If the patient is, the study will be explained to the participant and written consent will be obtained after participant is given the opportunity to have all questions answered.

The study is randomized, double-blind, placebo-controlled trial involving 2 arms. Participants will first complete a survey to collect demographic data.

Participants in both arms will receive the institution's current standard analgesia for cervical dilator placement. In addition to this standard regimen, participants will be randomized to receive either: (1) a dose of two oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone prior to cervical dilator placement.

Arms: arm 1: Two oral placebo pills (microcrystalline cellulose capsules) arm 2: 1 mg of oral lorazepam and 5 mg of oral oxycodone (also encased in microcrystalline cellulose capsules)
Interventions: intervention 1: Oxycodone and Lorazepam (Active Comparator) intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Oxycodone and Lorazepam intervention 2: Placebo oral pills

Protocol documents:
Prot_SAP_000.pdf: 
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Oral Sedation During Cervical Dilator 
Placement: A Randomized Controlled Trial 
 
 
 
 
 
 
 
NCT03202550 
 
 
 
 
 
 
 
3/17/2018 
 
 
 
 


  
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Date: _____________3/17/2018_____     
Principal Investigator: ____Jessica Lee__________ Application 
Number: __ IRB00117627 ____  
  
JHM IRB - eForm A – Protocol  
  
  
  
• 
Use the section headings to write the JHM IRB eForm A, inserting the appropriate material in each. 
If a section is not applicable, leave heading in and insert N/A.  
• 
When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at the 
top of JHM IRB eForm A.  
  
************************************************************************************** 
*************  
  
  
1.  
Abstract  
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research.  
  
Abortion during the second trimester of pregnancy accounts for approximately 11% of abortions performed 
in the United States1 and dilation and evacuation (D&E) is the most common method used.2 Cervical 
preparation with osmotic dilators is common practice for D&E beyond 14 weeks.2  Generally, osmotic 
dilators are the most effective form of cervical preparation.   
  
Despite the widespread use of osmotic dilators for cervical preparation for D&E, there are minimal data 
regarding patient pain during dilator placement. Those studies that evaluate pain with dilator insertion and 
during the interval between insertion and the D&E procedure do so as a secondary outcome and find that 
pain with dilator placement is generally moderate.3-5 Thus, it is important that we investigate options for 
pain control during cervical dilator placement.  
  
Few studies have examined pain management specifically during cervical dilator placement. Additionally, 
no prior studies have examined the effect of oral sedation on pain during cervical dilator placement. Oral 
sedation has advantages over IV sedation as it is associated with decreased cost, generally fewer side 
effects, and is more feasible in an outpatient setting.   
Anecdotally, it is not uncommon for women to request sedation for dilator placement, but there are 
currently no data to support effectiveness of oral sedation for dilator placement. By making patients more 
comfortable, pain improvement during dilator placement may increase the number of dilators placed and 
the subsequent dilation at time of D&E. Our hypothesis is that oral sedation will have a clinically 
significant impact on decreasing pain scores during and immediately after cervical dilator placement.  
  
  
2. 
Objectives (include all primary and secondary objectives)  
  
1. Primary objective:   


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a. Determine if oral sedation has a clinically significant impact on pain scores (20 mm 
difference on a 100 mm VAS6) during and immediately after cervical dilator 
placement as compared to placebo among women presenting for second trimester 
surgical abortion Hypothesis: Oral sedation will significantly improve pain 
compared to placebo during cervical dilator placement.  
  
2. Secondary objectives:  
a. To describe the symptoms and adverse events with oral sedation for cervical dilator 
placement  
Hypothesis: There will be differences in symptoms and adverse events with oral 
sedation as compared to placebo. These differences are unlikely to be significant and 
this study is not powered to detect these differences.  
b. To evaluate whether oral sedation for cervical dilator placement is associated with 
decreased procedure time for dilator insertion (from the time of speculum placement 
to the time of the last dilator placement).  
Hypothesis: Oral sedation will be associated with a decrease in time for the dilator 
insertion procedure compared to placebo.  
c. To evaluate whether oral sedation for cervical dilator placement is associated with 
increased success with inserting intended number of dilators (or more than intended) 
(as determined by a standardized algorithm).   
  
Hypothesis: Oral sedation will be associated with an increase in success with 
inserting the intended number of dilators (or more than intended) compared to 
placebo.”  
3. 
Descriptive objective: To describe dilator pain experience between the time of dilator insertion 
and the time of D&E.   
  
3.  
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research)  
  
Background: Few studies have examined pain management specifically during cervical dilator placement. 
One study found that intrauterine lidocaine (5cc of 2% lidocaine) combined with paracervical block did not 
improve pain control during laminaria insertion when compared with paracervical block and saline 
placebo.3 Another study found that a paracervical block (18 ccs of 1% lidocaine) compared to sham 
cervical block was effective in reducing pain after laminaria placement.7   
  
No prior studies have examined the effect of oral sedation on pain during cervical dilator placement. 
However, intravenous and oral sedation have been studied for pain management in the setting of surgical 
first and second trimester abortions. Regimens typically involve a combination of a benzodiazepine and an 
opiate medication.8-10 One prior study of women undergoing first trimester surgical abortions reported that 
women who received IV sedation prior to the procedure had lower pain scores compared to woman who 
received only local anesthesia.10 One study examining first trimester abortion found a small reduction in 
anxiety scores with the use of 1 mg oral lorazepam as compared to placebo, but no reduction in pain.11  
  
Experience: The division of Family Planning at Johns Hopkins has executed numerous prior clinical 
research projects including randomized clinical trials. The PI and other listed physician investigators all 
have experience with studies with a variety of methodologies and are experienced in performing the 


  
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cervical dilator placement procedure. Additionally, we have discussed this project with our pharmacy 
department and they have the ability to create our desired placebos.  
  
We also have the support of a dedicated research coordinator, nursing staff familiar with conducting 
clinical trials, and statistical support from BeadCORE.  
  
  
  
  
4.  
Study Procedures  
a. Study design, including the sequence and timing of study procedures    
(distinguish research procedures from those that are part of routine care).  
  
This will be a randomized, double- blind, placebo-controlled trial. We chose a randomized controlled trial 
as the study design given it is the gold standard for evaluating an intervention’s effectiveness. This trial 
will be done with adherence to the SPIRIT and CONSORT guidelines for clinical trials.12-13 The proposed 
randomized controlled trial will involve 2 arms.   
  
It should be noted that individuals engaged in the research involving a particular patient will have no part 
in any decision as to the timing, method, or procedures used to terminate a pregnancy for that particular 
patient. (Please see details in study methodology below.)  
  
  
Study methodology for this study will proceed as follows:  
1. Eligible women between 17w0d and 23w6d gestational age (GA) presenting for cervical dilator 
placement prior to their D&E procedure who arrive with a support person will be approached 
regarding the study prior to dilator placement. We will be recording in a tally (no PHI information) 
how many patients meet our gestational age criteria, ,how many agree to hearing about the study the 
day of the study visit, and of those, how many meet full eligibility criteria After discussing the 
study with the study team, those who decline or are ineligible to participate will be tallied. We will 
also record the gestational age, main reasons for declining or main reasons for ineligibility (no PHI 
information). These tallies and information will be recorded in an excel file on a secure server or 
REDCAP. Informed consent will be obtained if the patient agrees to participate (see Written 
Consent in Section 15 of IRB application).   
a. The consent process will only take place once the patient has gone through pregnancy options 
counseling, and made the decision to proceed with the procedure and signed the appropriate 
consent forms for the abortion procedure. As such, the research study will not interfere with 
their decision to terminate their pregnancy or impact the timing, method, or procedures by 
which termination will be performed.  
A test text message will be sent to the patient’s cell phone, confirming their phone works with our 
SMS system. We will ensure through the consent that subjects are encouraged to have security 
features enabled on their phone to prevent their text messages from being read by others.   
2. We will collect survey data via tablet device on the subject’s sociodemographic characteristics and 
pertinent medical history. (see Section 20, Supplemental Study Documents: Supplemental 
Survey/Assessments) We will record baseline pain prior to any medication administration.  
a. Survey data to be collected: participant’s age, race/ethnicity, level of education, pertinent 
gynecological history, medical and mental health history, benzodiazepine and opiate use, 


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current medications, tobacco use, alcohol use, drug use, and history of intimate partner violence.  
EMR data to be collected: BMI data, obstetric history, prior abortion history, details regarding 
whether this pregnancy is a desired but anomalous fetus (all details that are routinely recorded 
as part of the documentation for the dilator visit).  
3. Subjects in both arms will receive our institution’s current standard pre-procedure analgesia for 
cervical dilator placement: oral ibuprofen (600 mg given 30 minutes prior to the procedure). In 
addition to this standard regimen, subjects will be randomized to receive either: (1) a dose of two 
oral sublingual pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone given 45-60 
minutes prior to the start of the procedure.  
a. The subject, provider, and nursing staff will be blinded to the intervention. Our pharmacy will 
prepare the treatment drugs and placebos. Two research staff members will review and sign off 
verifying that drug or placebo has been provided correctly based on randomization. Following 
this, they will perform and document a cycle count of each investigational product for this 
study. Randomization will be stratified by gestational age (>= 20 weeks or <20 weeks) and the 
randomization allocation sequence will be computer-generated with a random number generator 
by a statistician. Our research assistant will be aware of the assignment and the physician who 
orders the study drug (oral sedation or placebo) will not be the same physician involved in the 
timing, method, or procedures of the patient’s pregnancy termination that day. Additionally, our 
research coordinator who is engaging in the research activities with the patient will not be 
involved in any decision as to the timing, method, or procedures used to terminate the patient’s 
pregnancy.  
4. The primary outcome of interest, pain score, will be recorded via tablet device on a 100 mm visual 
analog scale (0 mm= no pain, 100 mm= worst pain possible) after the last dilator is placed. 
Secondary outcomes will be pain levels measured at seven other time points: (1) baseline before 
medication, (2) baseline after medication, (3) speculum placement, (4) tenaculum placement, (5) 
after paracervical block, (6) after first dilator placed, and (7) 15 minutes after the last dilator is 
placed. The cervical dilator procedure will otherwise be routine.  
a. Paracervical block: Subjects will receive the standard procedural analgesia paracervical block 
involving 20 ccs of 1% lidocaine prior to cervical dilator placement  
b. We will allow attendings, fellows, and residents to take part in cervical dilator placement as per 
routine, and our research assistant will record the level of training of the provider who inserts 
the majority of the dilators. None of these physicians taking care of an individual patient will be 
involved in the research procedures of ordering the study drug.  
c. We will be measuring time from speculum placement until last dilator placement. The provider 
will also be asked regarding the ease of dilator placement after the last dilator has been placed.  
5. Additional outcomes to be assessed via tablet device will be symptoms (nausea, vomiting, 
dizziness, drowsiness, etc.) experienced by subjects as reported 15 minutes after dilator placement. 
(see Section 20, Supplemental Study Documents: Supplemental Survey/Assessments). We will 
extract data from the subject’s chart regarding number of dilators placed and the adverse events that 
occurred during the dilator placement visit (syncope or vasovagal reaction, cervical laceration, 
respiratory depression, etc.) after the visit. (see Section 20, Supplemental Study Documents: EMR 
data to be obtained). If the intended number (or more than intended number) of dilators is placed 
that will be considered a success in placing the intended number of dilators and if less than the 
intended number of dilators is placed that will be considered a non-success in placing the intended 
number of dilators.   
6. Women will be discharged home with standard prescriptions for ibuprofen 800 mg and oxycodone 
5 mg to take as needed.  
7. Participants will be contacted via text message at 2, 4, and 8 hours after dilator insertion   


  
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a. Text messages will originate from a password protected study cell phone. The Android 
application “SMS Scheduler” will be used to send standardized text messages to the participant 
at pre-programed time intervals from time of dilator insertion.   
b. Text messages content:  
i. 
Current Numeric Rating Scale (NRS) pain score  
ii. Inventory of analgesic use since last contact  
iii. Presence of symptoms  
8. Upon admission prior to D&E, we will document the time and assess the current NRS pain score, 
additional analgesic use since 8-hour text message contact, and presence of symptoms.  
9. Subjects will be financially compensated (with a $100 gift card and parking voucher the day of their 
D&E) for study participation after presenting for their D&E. They and their support person will also 
receive a $6 meal voucher. They will be compensated an additional $5 for each completed text 
message contact (at 2,4, and 8 hours).  
Approach of potential subjects: We will introduce the study via telephone during their routine cervical 
dilator appointment intake call prior to their visit. (see Section 13, Part 7: Telephone screening script) We 
will keep a log tally (no PHI information recorded) of the number of those who agreed to hear more about 
the study and those who did not. We are introducing the study via telephone because enrollment in the 
study will require that subjects have someone to escort them home (support person) and we do not want 
women to be ineligible if they desire to be in the study but they fail to bring a support person the day of 
their cervical dilator appointment. Our clinic nurse will briefly introduce the study and the need to bring a 
support person if the patient wants to be eligible. The consent for the study will be conducted at the time of 
the clinical visit for cervical dilator placement and after the patient decision regarding termination has been 
made and after surgical consents for the abortion procedure have been signed.  
  
The proposed research will require the use of hospital EMR to ensure we capture all side effects/symptoms 
and adverse events and to also assess the number of dilators placed by the physician. We are requesting 
access to EMR in our IRB protocol.  
  
b. Study duration and number of study visits required of research participants.  
  
Our primary aim is to be able to detect a clinically significant difference in pain after the last dilator is 
placed. Given a review of prior literature addressing pain during procedures that involve the cervix (i.e. 
IUD insertion, 1st trimester abortion) in addition to our calculations, we have determined 60 subjects will 
be needed to adequately power the study.  
  
Given that we see 15 women who would meet inclusion criteria per month, we expect overall length of 
enrollment to be approximately 8 months, accounting for a 50% non-enrollment rate. Study visits required 
of participants involve the cervical dilator placement visit and the visit for their following D&E procedure 
the next day, both of which are routine for women undergoing 2nd trimester abortion.  
  
We received IRB approval and our grant award. We anticipate enrollment to extend from July 2017 until  
August 2018 when we will reach our sample size. We anticipate data cleaning and analysis to take from 
August 2018-September 2018 with the help of our consultants at BeadCORE. Report writing will take 
place from September to October 2018. In summary, we will start enrollment July 2017 and our goal end 
date will be August 30, 2018.   
  
c. Blinding, including justification for blinding or not blinding the trial, if applicable.   


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The subject, provider, and nursing staff will be blinded to the intervention. Our pharmacy will prepare the 
treatment drugs and placebos. Randomization will be stratified by gestational age (>= 20 weeks or <20 
weeks) and the randomization allocation sequence will be computer-generated with a random number 
generator by a statistician. Our research assistant will be aware of the assignment and pass the treatment 
drugs on to the nursing staff who will administer the drugs to the subject.  
d. Justification of why participants will not receive routine care or will have current therapy 
stopped.  
  
Patients will receive routine care with the addition of being randomized to receive either: (1) a dose of two 
oral placebo pills, or (2) 1mg of oral lorazepam with 5 mg of oral oxycodone given 45-60 minutes prior to 
the procedure. No current therapy will be stopped.  
  
e. Justification for inclusion of a placebo or non-treatment group.  
No prior studies have examined the effect of oral sedation on pain during cervical dilator placement. Most 
patients currently undergo this procedure without oral sedation. Thus, there is no current evidence 
regarding whether the provision of oral sedation for cervical dilator placement will improve pain during the 
procedure. A placebo is justified in this setting of clinical equipoise.  
  
f. Definition of treatment failure or participant removal criteria.  
In our study there is no treatment failure situation as we do not anticipate a certain result with either study 
arm. Study discontinuation (participant removal) will occur when a subject takes the study drug but then 
declines or is unable to proceed with cervical dilator placement. Subjects may also request to discontinue at 
any time.  
  
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely.  
The patients will only be receiving the study therapy/intervention during their cervical dilator visit. The end 
of the study is when they complete their D&E procedure.  For subjects that do not follow up for their D&E 
the day following their cervical dilator placement (an extremely rare occurrence), we will follow our clinic 
protocol regarding contacting the subject. Subjects lost to follow up will be included in the primary 
outcome analysis.  
  
Any subjects who discontinue the study or do not follow up on the day of their D&E will be analyzed using 
intention to treat analysis.   
  
5. 
Inclusion/Exclusion Criteria  
Inclusion criteria: To be eligible for the study, women must be aged 18-50 years, English speaking, with an 
intrauterine pregnancy (either viable or non-viable) between the gestational ages of 17w0d and 23w6d 
presenting for cervical dilator placement prior to their D&E procedure. They must have a support person 
present with them at the time of their dilator placement.   
1. We will not enroll non- English speaking participants, however we will allow a participant 
who has a hearing impairment to be consented if they can read English and if they have an 
American Sign Language interpreter to assist in the consent process and study participation.  
2. For the exploratory objective, they must have cell phone that is capable of text messaging. 
This will be tested upon enrollment. If they do not have a cell phone, they will still be 
eligible for the main study, and if enrolled, will be excluded from steps 7 and 8 of the study 
methodology as described in the Study Procedures section.   


  
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Exclusion criteria: Women will be excluded if they are non-English-speaking, are taking a daily 
benzodiazepine or opiate, or have a known allergy or contraindication to NSAIDs, opiates, or 
benzodiazepines. We feel it is important to exclude women who are taking a daily benzodiazepine or opiate 
as they will likely have tolerance to the intervention drugs at our selected study doses and respond 
differently from other women.   
  
6. 
Drugs/ Substances/ Devices  
a. 
The rationale for choosing the drug and dose or for choosing the device to be used. We 
choose the intervention drugs lorazepam and oxycodone because sedation regimens 
previously  studied for pain management in the setting of surgical first and second trimester 
abortions typically involve a combination of a benzodiazepine and an opiate medication.8-10  
  
We chose the drug doses to be 1 mg of lorazepam and 5 mg of oxycodone to minimize the possibility that 
subjects would feel very symptomatic or lethargic (anecdotally we have seen this happen to lower weight 
patients (BMI<25kg/m2) in clinic taking a combination of 2 mg of lorazepam and 10 mg of oxycodone). 
We discussed with our research pharmacy team the utility of studying a 2 mg lorazepam dose in the setting 
of increased BMI, however per their recommendations there is little evidence to support an increased dose 
for increased BMI.   
b. 
Justification and safety information if FDA approved drugs will be administered for non-
FDA approved indications or if doses or routes of administration or participant populations 
are changed. N/A  
c. 
Justification and safety information if non-FDA approved drugs without an IND will be 
administered. N/A  
  
7. 
Study Statistics  
a. 
Primary outcome variable.  
The primary outcome of interest, pain score, will be measured via tablet device on a 100 mm visual analog 
scale (0 mm= no pain, 100 mm= worst pain possible) after the last dilator is placed.   
b. 
Secondary outcome variables.  
Secondary outcomes will be pain levels measured at seven other time points: (1) baseline before 
medication, (2) baseline after medication, (3) speculum placement, (4) tenaculum placement, (5) after 
paracervical block, (6) after first dilator placed, and (7) 15 minutes after the last dilator is placed. The 
cervical dilator procedure will otherwise be routine.  
  
Additional outcomes to be assessed via tablet device will be symptoms (nausea, vomiting, dizziness, 
drowsiness, etc.) experienced by subjects as reported 15 minutes after dilator placement. We will extract 
data from the subject’s chart regarding number of dilators placed and the adverse events that occurred 
during the dilator placement visit (syncope or vasovagal reaction, cervical laceration, respiratory 
depression, etc.) after the visit.   
  
As part of our exploratory objective we will also be looking at the additional outcomes pain, analgesic use, 
and presence of symptoms 2,4, and 8 hours after dilator insertion.  
  
c. 
Statistical plan including sample size justification and interim data analysis.  
Our primary aim is to be able to detect a clinically significant difference in pain after the last dilator is 
placed. Given a review of prior literature addressing pain during procedures that involve the cervix (i.e. 


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IUD insertion, 1st trimester abortion) in addition to our calculations, we have determined 60 subjects will 
be needed to adequately power the study to detect a clinically significant difference in visual analog pain 
scores of 20 mm6 at a given instance and obtain 80% power with a 5% alpha error rate.  This plan was 
formulated with our consultants at BeadCORE.  
  
Given our small sample size we will perform our interim data analysis when we have data from 75% of our 
sample size.   
  
d. 
Early stopping rules.  
If we find the adverse event rate to be significant (p<0.05) in our intervention arm (at the time of interim 
analysis) we will consider stopping the study early.  
  
8. 
Risks  
a. 
Medical risks, listing all procedures, their major and minor risks and expected frequency.  
  
There are risks to taking oral sedation including lethargy, syncope, and respiratory depression. We chose 
the intervention drug doses to be 1 mg of lorazepam and 5 mg of oxycodone to minimize the possibility 
that subjects would feel very symptomatic or lethargic. We will have a trained nurse administering the drug 
to the patient and with the patient during the entirety of the cervical dilator placement. The patient will 
recover in the waiting room where a nurse and physician will be readily accessible to assess and address 
any side effects that the subject may have to the oral sedation. This is the standard clinical care that is 
currently practiced in the clinic.  
  
There are no additional procedures expected with the cervical dilator placement visit.   
  
b. 
Steps taken to minimize the risks.  
See part a.  
  
c. 
Plan for reporting unanticipated problems or study deviations.  
  
Any unanticipated problems or study deviations will be immediately reported to our research coordinator 
and subsequently evaluated with the PI. If necessary, problems that lead to protocol change or study 
deviations will be reported to the IRB.  
  
d. 
Legal risks such as the risks that would be associated with breach of confidentiality.  
  
There is a possibility for breach of confidentiality if protected health information that is identifiable is not 
protected. To prevent this, REDCap data (all the data collected at cervical dilator visit) will be password 
protected, and stored on the secure web application.   
  
All other data will be de-identified and stored on a secure server within the university. Any hard copies of 
data (i.e. consents) will be stored in a locked file cabinet inside a locked office within the university.    
  
There is also a potential for breach of confidentiality during the text message portion of the study. Prior to 
first text message, the research assistant will program the participant into the phone contact list with their 
study number and preferred phone number. Text message responses will be input into the study database on 
REDCap on a weekly basis and the participant’s contact information and text messages deleted from the 
phone. Special attention will be paid to ensuring participant privacy as communication is undertaken with 


  
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them (no text messages will use the words “pregnancy” or “abortion”) while they are at home and 
potentially around others not aware of their pregnancy or abortion decision. We will ensure through the 
consent that subjects are encouraged to have security features enabled on their phone to prevent their text 
messages from being read by others. We have also confirmed that the text messaging application does not 
use a cloud storage for text messaging data; it is unlikely that text messages would be accessed by anyone 
but the sender and receiver. Though it is likely that the text messages are encrypted, we have included 
additional detail regarding the risks of unencrypted data in our informed consent. We have received written 
approval from Darren Lacey, Chief Information Security Officer, regarding the use of the text messaging 
application in our study.  
  
e. 
Financial risks to the participants.  
  
The only possible financial risk to the participant is if they have a per-text messaging fee associated with 
their phone service. In these situations, participants will be compensated for text messaging fees related to 
the study.  
  
9. 
Benefits  
a. 
Description of the probable benefits for the participant and for society.  
  
Participant benefits: The participant may find a benefit of decreased pain during and after the procedure if 
they are assigned the treatment drug arm. They will also be financially compensated for participating in the 
study, see above and also reiterated in next section.   
  
Society benefits: Findings from this study could help improve approaches to second trimester D&E cervical 
preparation, addressing a 2016 Fellowship in Family Planning Research Priority. Minimal literature 
currently exists regarding pain management specifically during dilator placement. There is no data 
regarding the dosage of benzodiazepines or opiate medications that are effective for pain management 
during dilator placement. This study would also add to limited data regarding baseline pain during dilator 
placement and the pain course after dilator placement. From our experiences in running the study, we hope 
to develop a standardized clinic protocol for those who desire oral sedation for dilator placement.   
  
10. 
Payment and Remuneration  
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol.  
  
Subjects will be financially compensated (with a $100 gift card and parking voucher the day of their D&E) 
for study participation after presenting for their D&E or immediately after their dilator placement visit if 
they are not participating in the text messaging portion of the study. They and their support person will also 
receive a meal voucher (value $6 each). They will be compensated an additional $5 bonus for each 
completed text message contact (at 2,4, and 8 hours). Thus, they can be compensated a maximum of $115 
if they complete all parts of the study.   
  
The participants must show up the next day for their D&E to be compensated for the text messaging 
portion of the study (this is stated in the consent). Thus, if they do not show up for their D&E they will not 
have completed the protocol and will not be compensated for the text messaging portion (not presenting for 
D&E is extremely rare). There are no reductions or penalties otherwise.  
  


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11. 
Costs  
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them.  
  
There will be no additional cost to the patients beyond what is routine for the cervical dilator visit and 
D&E.   
  
The study drugs (both placebo and oral sedation drugs) will be covered with a grant from the Society of 
Family Planning. Text messaging fees (if they apply to participants’ phone plans) will be covered by the 
same grant.   
  
  
  
References  
  
1. 
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